Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-28 @ 11:31 PM
Study NCT ID:
NCT01693692
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2012-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of TD-9855 to Treat Fibromyalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@theravance.com', 'phone': '1-855-633-8479', 'title': 'Medical Monitor', 'organization': 'Theravance Biopharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 1 up to Day 63', 'description': 'Only data from participants who received study drug or placebo is included here.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants will be administered a placebo once daily for 6 weeks.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 71, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TD-9855 Group 1', 'description': 'Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 127, 'otherNumAffected': 78, 'seriousNumAtRisk': 127, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'TD-9855 Group 2', 'description': 'Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 90, 'seriousNumAtRisk': 128, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Macrocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Postural orthostatic tachycardia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Blindness transient', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dental discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Infrequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Lip pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Sluggishness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Menstruation delayed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Skin hypopigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Transient neurological symptoms of unknown etiology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 128, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be administered a placebo once daily for 6 weeks.'}, {'id': 'OG001', 'title': 'TD-9855 Group 1', 'description': 'Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}, {'id': 'OG002', 'title': 'TD-9855 Group 2', 'description': 'Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '-1.4', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0277', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with available data were used for this analysis.'}, {'type': 'SECONDARY', 'title': 'Fibromyalgia Impact Questionnaire (FIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be administered a placebo once daily for 6 weeks.'}, {'id': 'OG001', 'title': 'TD-9855 Group 1', 'description': 'Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}, {'id': 'OG002', 'title': 'TD-9855 Group 2', 'description': 'Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.0', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '42.4', 'spread': '1.75', 'groupId': 'OG001'}, {'value': '38.2', 'spread': '1.75', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2637', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-1.57', 'ciUpperLimit': '2.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.48', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0097', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-5.80', 'ciUpperLimit': '-1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.47', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 43 (End of study treatment)', 'description': 'FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with available data were used for this analysis.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants will be administered a placebo once daily for 6 weeks.'}, {'id': 'OG001', 'title': 'TD-9855 Group 1', 'description': 'Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}, {'id': 'OG002', 'title': 'TD-9855 Group 2', 'description': 'Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0639', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.24', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0070', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-0.39', 'ciUpperLimit': '-0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 43 (End of study treatment)', 'description': "PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with available data were used for this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants will be administered a placebo once daily for 6 weeks.'}, {'id': 'FG001', 'title': 'TD-9855 Group 1', 'description': 'Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}, {'id': 'FG002', 'title': 'TD-9855 Group 2', 'description': 'Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '131'}, {'groupId': 'FG002', 'numSubjects': '131'}]}, {'type': 'Received Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '97'}, {'groupId': 'FG002', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '392 participants were enrolled across 53 study sites in the United States.', 'preAssignmentDetails': '392 participants were enrolled, but 9 participants were not treated with the study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '392', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants will be administered a placebo once daily for 6 weeks.'}, {'id': 'BG001', 'title': 'TD-9855 Group 1', 'description': 'Participants will be administered TD-9855 at an initial dose of 2.5 mg once daily for 1 week, before increasing the dose to 5 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}, {'id': 'BG002', 'title': 'TD-9855 Group 2', 'description': 'Participants will be administered TD-9855 at an initial dose of 10 mg once daily for 1 week, before increasing the dose to 20 mg once daily for the following 5 weeks. Participants who are unable to tolerate the initial dose level will be discontinued from further dosing and will be considered to have withdrawn prematurely from the study.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '65.0'}, {'value': '48.0', 'groupId': 'BG001', 'lowerLimit': '19.0', 'upperLimit': '65.0'}, {'value': '43.2', 'groupId': 'BG002', 'lowerLimit': '19.0', 'upperLimit': '65.0'}, {'value': '45.7', 'groupId': 'BG003', 'lowerLimit': '18.0', 'upperLimit': '65.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age (years)', 'categories': [{'title': '18 - 45 Years of Age', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}, {'title': '46 - 65 Years of Age', 'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '213', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}, {'value': '369', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}, {'value': '333', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '324', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '131', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}, {'value': '392', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.9', 'spread': '17.64', 'groupId': 'BG000'}, {'value': '83.2', 'spread': '17.68', 'groupId': 'BG001'}, {'value': '79.0', 'spread': '17.27', 'groupId': 'BG002'}, {'value': '81.4', 'spread': '17.57', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.3', 'spread': '6.85', 'groupId': 'BG000'}, {'value': '164.5', 'spread': '7.65', 'groupId': 'BG001'}, {'value': '164.0', 'spread': '8.49', 'groupId': 'BG002'}, {'value': '164.0', 'spread': '7.69', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.7', 'spread': '6.24', 'groupId': 'BG000'}, {'value': '30.7', 'spread': '5.74', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '5.59', 'groupId': 'BG002'}, {'value': '30.2', 'spread': '5.89', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 392}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2018-09-10', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2012-09-20', 'dispFirstSubmitQcDate': '2018-09-10', 'resultsFirstSubmitDate': '2022-02-09', 'studyFirstSubmitQcDate': '2012-09-24', 'dispFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-09', 'studyFirstPostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries', 'timeFrame': 'Baseline and Week 6', 'description': 'Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.'}], 'secondaryOutcomes': [{'measure': 'Fibromyalgia Impact Questionnaire (FIQ)', 'timeFrame': 'Day 43 (End of study treatment)', 'description': 'FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.'}, {'measure': 'Patient Global Impression of Change (PGIC)', 'timeFrame': 'Day 43 (End of study treatment)', 'description': "PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fibromyalgia'], 'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '32856281', 'type': 'DERIVED', 'citation': 'Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* • American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)\n\n * Informed consent\n * 18 to 65 years of age\n * Discontinue therapy with adrenergic-acting drugs, and certain other medications\n\n * Only acetaminophen or NSAID as rescue pain medication\n * No narcotic pain meds or benzodiazepines\n * Only non-benzodiazepines as rescue hypnotics\n\nExclusion Criteria:\n\n* Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)\n* Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)\n* Risk of suicide (investigator opinion and/or C-SSRS)\n* Recent history of substance or alcohol abuse\n* BMI \\<18 or ≥45\n* Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea\n* Abnormal lab values (liver, kidney, thyroid, and others)"}, 'identificationModule': {'nctId': 'NCT01693692', 'briefTitle': 'Phase 2 Study of TD-9855 to Treat Fibromyalgia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Theravance Biopharma'}, 'officialTitle': 'A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)', 'orgStudyIdInfo': {'id': '0092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TD-9855 Group 1', 'description': 'Group 1 to be dosed with TD-9855', 'interventionNames': ['Drug: TD-9855 Group 1']}, {'type': 'EXPERIMENTAL', 'label': 'TD-9855 Group 2', 'description': 'Group 2 to be dosed with TD-9855', 'interventionNames': ['Drug: TD-9855 Group 2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group to be dosed with Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TD-9855 Group 1', 'type': 'DRUG', 'armGroupLabels': ['TD-9855 Group 1']}, {'name': 'TD-9855 Group 2', 'type': 'DRUG', 'armGroupLabels': ['TD-9855 Group 2']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rheumatology Associates of North Alabama, PC', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dedicated Clinical Research', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '92020', 'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'facility': 'TriWest Research Associates, LLC', 'geoPoint': {'lat': 32.79477, 'lon': -116.96253}}, {'zip': '93449', 'city': 'Pismo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Arroyo Medical Group, Inc.', 'geoPoint': {'lat': 35.14275, 'lon': -120.64128}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Diablo Clinical Research, Inc.', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '06320', 'city': 'New London', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Coastal Connecticut Research, LLC', 'geoPoint': {'lat': 41.35565, 'lon': -72.09952}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Clinical Research Center, LLC', 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-95.94043}}, {'zip': '89123', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Advanced Biomedical Research of America', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Clinical Research Associates, LLC', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Research Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58103', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Lillestol Research, LLC', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43551', 'city': 'Perrysburg', 'state': 'Ohio', 'country': 'United States', 'facility': 'Clinical Research Source, Inc.', 'geoPoint': {'lat': 41.557, 'lon': -83.62716}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Tulsa Clinical Research, LLC', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Sunstone Medical Research, LLC', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Omega Medical Research', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Coastal Carolina Research Center', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Carolina Center for Rheumatology & Arthritis Care', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '57049', 'city': 'Dakota Dunes', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 42.48749, 'lon': -96.48642}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'ClinSearch, LLC', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Rheumatology Research', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theravance Biopharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theravance Biopharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}