Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT05080660
Status:
COMPLETED
Last Update Posted:
2024-07-17
First Post:
2021-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800- 545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Week 8', 'description': 'All participants under the safety population for week 1-4 and week 5-8.', 'eventGroups': [{'id': 'EG000', 'title': '250 mg LY3526318 (Week 1 to 4)', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks of treatment period (Week 1-4).', 'otherNumAtRisk': 107, 'deathsNumAtRisk': 107, 'otherNumAffected': 31, 'seriousNumAtRisk': 107, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '250 mg LY3526318/Placebo (Week 5 to 8)', 'description': 'Participants who received 250 mg of LY3526318 in the first 4 weeks were switched to received placebo once daily for the next 4 weeks of the treatment period (Week 5-8).', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 13, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo (Week 1 to 4)', 'description': 'Participants received placebo orally, once daily, for week 1 to 4 of treatment period.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 21, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo (Week 5 to 8)', 'description': 'Participants received placebo orally, once daily, for week 5 to 8 of treatment period.', 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 8, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Persistent genital arousal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Trigeminal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Anti-muscle specific kinase antibody', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 25.0'}, 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{'groupId': 'EG002', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': 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Here, the overall number of participants analyzed includes number of participants with non-missing values at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.26', 'groupId': 'OG000', 'lowerLimit': '-1.60', 'upperLimit': '-0.93'}, {'value': '-1.45', 'groupId': 'OG001', 'lowerLimit': '-1.92', 'upperLimit': '-0.99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.76', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes number of participants with non-missing values at Week 8.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.87', 'groupId': 'OG000', 'lowerLimit': '-2.40', 'upperLimit': '-1.36'}, {'value': '-2.50', 'groupId': 'OG001', 'lowerLimit': '-3.21', 'upperLimit': '-1.79'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '1.47', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 5 questions on the pain subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0 = no pain, and 4 = extreme pain. The scores for the pain subscale were calculated by summing the scores of the questions for each participant at each time point. The range of possible scores is 0 to 20 for the pain subscale. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.51', 'groupId': 'OG000', 'lowerLimit': '-3.15', 'upperLimit': '-1.87'}, {'value': '-2.85', 'groupId': 'OG001', 'lowerLimit': '-3.69', 'upperLimit': '-1.99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '1.34', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 5 questions on the pain subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0=no pain, and 4=extreme pain. The scores for the pain subscale were calculated by summing the scores of the questions for each participant at each time point. The range of possible scores is 0 to 20 for the pain subscale. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the WOMAC® Stiffness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.04', 'groupId': 'OG000', 'lowerLimit': '-1.32', 'upperLimit': '-0.76'}, {'value': '-1.11', 'groupId': 'OG001', 'lowerLimit': '-1.48', 'upperLimit': '-0.75'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.50', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 2 questions in the stiffness subscale and participants used a 0 to 4 Likert scale to answer each question for the current day: 0=no stiffness, and 4=extreme stiffness. The scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 8 for the stiffness subscale.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the WOMAC® Stiffness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.16', 'groupId': 'OG000', 'lowerLimit': '-1.46', 'upperLimit': '-0.86'}, {'value': '-1.26', 'groupId': 'OG001', 'lowerLimit': '-1.65', 'upperLimit': '-0.87'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.55', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 2 questions in the stiffness subscale and participants used a 0 to 4 Likert scale to answer each question for the current day: 0 = no stiffness, and 4 = extreme stiffness. The scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 8 for the stiffness subscale.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the WOMAC® Physical Function Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.48', 'groupId': 'OG000', 'lowerLimit': '-8.21', 'upperLimit': '-4.76'}, {'value': '-8.46', 'groupId': 'OG001', 'lowerLimit': '-10.86', 'upperLimit': '-6.10'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.98', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '4.88', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 17 questions in the physical function subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0=no difficulty, and 4=extreme difficulty. The scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 68 for the physical function subscale.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the WOMAC® Physical Function Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.04', 'groupId': 'OG000', 'lowerLimit': '-10.07', 'upperLimit': '-6.01'}, {'value': '-11.09', 'groupId': 'OG001', 'lowerLimit': '-13.82', 'upperLimit': '-8.33'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.05', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '6.38', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 17 questions in the physical function subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0=no difficulty, and 4=extreme difficulty. The scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 68 for the physical function subscale.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change", 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.18', 'groupId': 'OG000', 'lowerLimit': '2.97', 'upperLimit': '3.40'}, {'value': '3.05', 'groupId': 'OG001', 'lowerLimit': '2.75', 'upperLimit': '3.35'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.50', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': "Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change", 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '2.74', 'upperLimit': '3.18'}, {'value': '2.97', 'groupId': 'OG001', 'lowerLimit': '2.66', 'upperLimit': '3.28'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.39', 'ciUpperLimit': '0.37', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': "Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Worst Pain Intensity as Measured by NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.08', 'groupId': 'OG000', 'lowerLimit': '-1.38', 'upperLimit': '-0.79'}, {'value': '-1.38', 'groupId': 'OG001', 'lowerLimit': '-1.79', 'upperLimit': '-0.97'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.81', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Worst Pain Intensity as Measured by NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'groupId': 'OG000', 'lowerLimit': '-1.76', 'upperLimit': '-1.05'}, {'value': '-1.70', 'groupId': 'OG001', 'lowerLimit': '-2.19', 'upperLimit': '-1.21'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.90', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Visual Analog Scale (VAS) for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.69', 'groupId': 'OG000', 'lowerLimit': '-15.47', 'upperLimit': '-7.87'}, {'value': '-17.82', 'groupId': 'OG001', 'lowerLimit': '-23.08', 'upperLimit': '-12.61'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.14', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '12.52', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Visual Analog Scale (VAS) for Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.41', 'groupId': 'OG000', 'lowerLimit': '-20.55', 'upperLimit': '-12.32'}, {'value': '-21.55', 'groupId': 'OG001', 'lowerLimit': '-27.30', 'upperLimit': '-15.81'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.15', 'ciLowerLimit': '-1.90', 'ciUpperLimit': '12.18', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': 'VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-0.14', 'upperLimit': '0.22'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '-0.18', 'upperLimit': '0.31'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.27', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': "The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.", 'unitOfMeasure': 'Hours per night', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'groupId': 'OG000', 'lowerLimit': '-0.21', 'upperLimit': '0.19'}, {'value': '0.19', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.45'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.13', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': "The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.", 'unitOfMeasure': 'Hours per night', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}, {'type': 'SECONDARY', 'title': 'Total Amount of Rescue Medication Use as Measured by Average Daily Dosage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '271.27', 'groupId': 'OG000', 'lowerLimit': '182.84', 'upperLimit': '359.36'}, {'value': '172.92', 'groupId': 'OG001', 'lowerLimit': '47.39', 'upperLimit': '296.22'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '98.35', 'ciLowerLimit': '-51.95', 'ciUpperLimit': '250.88', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 4', 'description': 'Total amount of rescue medication use as measured by average daily dosage. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'mg per day (mg/day)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': 'Total Amount of Rescue Medication Use as Measured by Average Daily Dosage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '284.83', 'groupId': 'OG000', 'lowerLimit': '185.06', 'upperLimit': '385.02'}, {'value': '161.47', 'groupId': 'OG001', 'lowerLimit': '22.36', 'upperLimit': '299.42'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '123.36', 'ciLowerLimit': '-46.51', 'ciUpperLimit': '293.69', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'Total amount of rescue medication use as measured by average daily dosage. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.', 'unitOfMeasure': 'mg/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) (United States)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.10'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.05', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': "The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.\n\nPosterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) (United States)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.10'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '-0.01', 'upperLimit': '0.12'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Posterior Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.00', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.07', 'estimateComment': 'Posterior mean difference with 95% credible interval is reported.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 8', 'description': "The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.\n\nPosterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug. Here, the overall number of participants analyzed includes the number of participants with non-missing value at Week 8.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '250 Milligram (mg) LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Received at Least One Dose of Study Drug (Safety Population Week 1-4)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Safety Population Week 5-8', 'comment': 'All participants who took at least 1 dose of study drug and who did not discontinue at or prior to week 4.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-compliance With Study Drug and Procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '250 mg LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63.9', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '62.7', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '63.5', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.52', 'spread': '1.60', 'groupId': 'BG000'}, {'value': '5.91', 'spread': '1.25', 'groupId': 'BG001'}, {'value': '5.65', 'spread': '1.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with non-missing baseline NRS data.'}], 'populationDescription': 'All enrolled or randomized participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-10', 'size': 4630844, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_004.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-28T03:55', 'hasProtocol': True}, {'date': '2022-06-13', 'size': 939439, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_005.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-05-28T03:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2021-10-10', 'resultsFirstSubmitDate': '2023-06-01', 'studyFirstSubmitQcDate': '2021-10-10', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-11', 'studyFirstPostDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, Week 4', 'description': 'The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)', 'timeFrame': 'Baseline, Week 8', 'description': 'The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale', 'timeFrame': 'Baseline, Week 4', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 5 questions on the pain subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0 = no pain, and 4 = extreme pain. The scores for the pain subscale were calculated by summing the scores of the questions for each participant at each time point. The range of possible scores is 0 to 20 for the pain subscale. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 5 questions on the pain subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0=no pain, and 4=extreme pain. The scores for the pain subscale were calculated by summing the scores of the questions for each participant at each time point. The range of possible scores is 0 to 20 for the pain subscale. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the WOMAC® Stiffness Subscale', 'timeFrame': 'Baseline, Week 4', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 2 questions in the stiffness subscale and participants used a 0 to 4 Likert scale to answer each question for the current day: 0=no stiffness, and 4=extreme stiffness. The scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 8 for the stiffness subscale.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the WOMAC® Stiffness Subscale', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 2 questions in the stiffness subscale and participants used a 0 to 4 Likert scale to answer each question for the current day: 0 = no stiffness, and 4 = extreme stiffness. The scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 8 for the stiffness subscale.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the WOMAC® Physical Function Subscale', 'timeFrame': 'Baseline, Week 4', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 17 questions in the physical function subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0=no difficulty, and 4=extreme difficulty. The scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 68 for the physical function subscale.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the WOMAC® Physical Function Subscale', 'timeFrame': 'Baseline, Week 8', 'description': 'The WOMAC® is a validated instrument that is extensively used to evaluate the response to medications for the treatment of Osteoarthritis pain. There are 17 questions in the physical function subscale, and participants used a 0 to 4 Likert scale to answer each question for the current day: 0=no difficulty, and 4=extreme difficulty. The scores for each subscale were calculated by summing the scores of the questions in each respective subscale for each participant at each time point. The range of possible scores is 0 to 68 for the physical function subscale.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': "Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change", 'timeFrame': 'Baseline, Week 4', 'description': "Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval."}, {'measure': "Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change", 'timeFrame': 'Baseline, Week 8', 'description': "Patients Global Impression of change captured the participant's perspective of treatment apart from sub-aspects of the general improvement. This is a numeric scale from 1 to 7: 1=very much better, and 7=very much worse.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval."}, {'measure': 'Change From Baseline for Worst Pain Intensity as Measured by NRS', 'timeFrame': 'Baseline, Week 4', 'description': 'The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline for Worst Pain Intensity as Measured by NRS', 'timeFrame': 'Baseline, Week 8', 'description': 'The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their worst pain over the past 24 hours, on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the Visual Analog Scale (VAS) for Pain', 'timeFrame': 'Baseline, Week 4', 'description': 'VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the Visual Analog Scale (VAS) for Pain', 'timeFrame': 'Baseline, Week 8', 'description': 'VAS was a graphic, single-item scale where participants were asked to describe their pain intensity over the past week, on a scale of 0 to 100: 0=no pain, and 100=worst imaginable pain. Participants completed the VAS by placing a line perpendicular to the VAS line at a point that described their pain intensity.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep', 'timeFrame': 'Baseline, Week 4', 'description': "The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval."}, {'measure': 'Change From Baseline on the Sleep Scale From the Medical Outcomes Study (MOS Sleep Scale) - Average Hours of Sleep', 'timeFrame': 'Baseline, Week 8', 'description': "The MOS Sleep Scale consists of 12 questions addressing the past week. Question 1 asks time to fall asleep and it is reported in 5-point timeframe categories. Question 2 asks average hours of sleep. In the remaining 10 questions participants report how often a sleep symptom or problem was present on a scale ranging from '0=all of the time' to '5=none of the time.' MOS Sleep scale dimension scores range from 0 to 100 with lower score indicating improvement, except for the dimension of sleep adequacy, where higher scores indicate improvement. Here, the average hours of sleep (i.e., Question 2) is reported as the average number of hours slept each night during the past week (range 0 to 24 hours). Higher number of hours slept indicates improvement.\n\nPosterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval."}, {'measure': 'Total Amount of Rescue Medication Use as Measured by Average Daily Dosage', 'timeFrame': 'Week 4', 'description': 'Total amount of rescue medication use as measured by average daily dosage. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Total Amount of Rescue Medication Use as Measured by Average Daily Dosage', 'timeFrame': 'Week 8', 'description': 'Total amount of rescue medication use as measured by average daily dosage. Posterior mean change from baseline, 95% credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.'}, {'measure': 'Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) (United States)', 'timeFrame': 'Baseline, Week 4', 'description': "The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.\n\nPosterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval."}, {'measure': 'Change From Baseline on the EuroQuality of Life Five Dimensions (5D) Five Level (5L) Questionnaire (EQ-5D-5L) (United States)', 'timeFrame': 'Baseline, Week 8', 'description': "The EQ-5D-5L assessed quality of life based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant was asked to 'check the ONE box that best describes your health TODAY,' choosing from 5 options (no problems, slight problems, moderate problems, severe problems, extreme problems) provided under each dimension. The scores in the 5 dimensions were summarized into a health state index score. The health state index value is a single value on a scale from less than 0 to 1 (negative values are valued as worse than dead) with higher scores indicating better health: 0=a health state equivalent to death, and 1=perfect health.\n\nPosterior mean change from baseline, 95% credible intervals was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis', 'Osteo Arthritis Knee']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/o5FS87tuIKFcTChW9I2GN', 'label': 'Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test safety and efficacy of study drug LY3526318 in for the treatment of knee pain due to with osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a visual analog scale (VAS) pain value ≥40 and \\<95 during screening.\n* Have a history of daily pain for at least 12 weeks based on participant report or medical history.\n* Have a body mass index \\<40 kilograms per meter squared (kg/m²) (inclusive).\n* Are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.\n* Are willing to discontinue all medications taken for chronic pain conditions for the duration of the study.\n* Have presence of index knee pain for \\>12 weeks at screening.\n* Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee.\n* Are men, or women able to abide by reproductive and contraceptive requirements.\n\nExclusion Criteria:\n\n* Have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques).\n* Have surgery planned during the study for any reason, related or not to the disease state under evaluation.\n* Have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.\n* Have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.\n* Have fibromyalgia\n* Have a substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association).\n* Have a positive human immunodeficiency virus (HIV) test result at screening.\n* Are in the judgment of the investigator, actively suicidal and therefore deemed to be at significant risk for suicide.\n* Have an intolerance to acetaminophen or paracetamol or any of its excipients.\n* Have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.\n* Are largely or wholly incapacitated and unable to participate fully in all protocol procedures, for example, bedridden or confined to a wheelchair, permitting little or no selfcare.\n* Have presence of surgical hardware or other foreign body in the index knee.\n* Have an unstable index joint (such as a torn anterior cruciate ligament).\n* Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to starting the washout period.\n* Have chronic pain syndrome, or other concurrent medical or arthritic conditions that could interfere with the evaluation of the index knee.\n* Have a history of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.\n* Have clinical signs and symptoms of active knee infection or crystal disease of the index knee.\n* Have a history of infection in the index joint.\n* Have a history of arthritis due to crystals (e.g., gout, pseudo gout).\n* Have pain or functional impairment due to ipsilateral hip osteoarthritis.\n* Are pregnant or breastfeeding."}, 'identificationModule': {'nctId': 'NCT05080660', 'briefTitle': 'Chronic Pain Master Protocol (CPMP): A Study of LY3526318 in Participants With Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY3526318 for the Treatment of Osteoarthritis Pain', 'orgStudyIdInfo': {'id': '17592'}, 'secondaryIdInfos': [{'id': 'H0P-MC-OA02', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3526318', 'description': 'Participants received 250 mg of LY3526318 orally, once daily for the first 4 weeks and were switched to placebo once daily for the next 4 weeks of the treatment period.', 'interventionNames': ['Drug: LY3526318']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo orally, once daily, for 8-weeks treatment period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY3526318', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3526318']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 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of Greater New Haven', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'VIN-Julie Schwartzbard', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Suncoast Research Group', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33165', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'New Horizon Research Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34470', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Renstar Medical Research', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Synexus Clinical Research US, Inc - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Synexus Clinical Research US, Inc.', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '32162', 'city': 'The Villages', 'state': 'Florida', 'country': 'United States', 'facility': 'Synexus Clinical Research US, Inc - Orlando', 'geoPoint': {'lat': 28.93408, 'lon': -81.95994}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Clinical Research', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60602', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Synexus Clinical Research US, Inc.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02131', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston Clinical Trials', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01844', 'city': 'Methuen', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'ActivMed Practices and Research', 'geoPoint': {'lat': 42.7262, 'lon': -71.19089}}, {'zip': '02451', 'city': 'Waltham', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'MedVadis Research Corporation', 'geoPoint': {'lat': 42.37649, 'lon': -71.23561}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Great Lakes Research Group, Inc.', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '63303', 'city': 'City of Saint Peters', 'state': 'Missouri', 'country': 'United States', 'facility': 'StudyMetrix Research', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '65810', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest Research LLC', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Synexus - Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45432', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'META Medical Research Institute', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center For Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Synexus - US', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Clinical Research Center', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98057', 'city': 'Renton', 'state': 'Washington', 'country': 'United States', 'facility': 'Rainier Clinical Research Center', 'geoPoint': {'lat': 47.48288, 'lon': -122.21707}}, {'zip': '00716', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Ponce Medical School Foundation Inc.', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Latin Clinical Trial Center', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], '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'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}