Viewing Study NCT01773993

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 1:10 AM
Ignite Modification Date: 2025-12-25 @ 11:21 PM
Study NCT ID: NCT01773993
Status: COMPLETED
Last Update Posted: 2023-10-10
First Post: 2013-01-18
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 weeks', 'description': 'The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion.", 'otherNumAtRisk': 499, 'deathsNumAtRisk': 499, 'otherNumAffected': 152, 'seriousNumAtRisk': 499, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': "Meniere's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperprolactinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Foreign body sensation in eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lip blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia chlamydial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lipids abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscle rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Affect lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 499, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Drug Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '25.45', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 1 to 52 weeks at maximum', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Drug Reaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 1 to52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '3.41', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 1 to 52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 1 to 52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 1 to 52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Drug Reactions Related to Vision-related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 1 to 52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure was the baseline analysis population, which comprised of participants who satisfied the criteria of safety analysis population and had received LYRICA Capsules at least once.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.67', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 52', 'description': 'The pain from fibromyalgia experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in the pain score at Week 52 was presented along with standard deviation.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of pain score was available among the baseline analysis population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Sleep Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 52', 'description': 'The quality of sleep experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (the best sleep possible) to 10 (the worst sleep possible). Mean change from baseline in quality of sleep score at Week 52 was presented along with standard deviation.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of quality of sleep score was available among the baseline analysis population.'}, {'type': 'SECONDARY', 'title': "Patient's Impression (PGIC) at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '416', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'title': 'Markedly improved', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}]}]}, {'title': 'Slightly improved', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': 'Slightly worsened', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Markedly worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Not assessed', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': "The patient's impression (patient global impression of change \\[PGIC\\]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PGIC was available among the baseline analysis population.'}, {'type': 'SECONDARY', 'title': "Physician's Impression (CGIC) at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'title': 'Markedly improved', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}]}]}, {'title': 'Slightly improved', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Slightly worsened', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Markedly worsened', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Not assessed', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': "The physician's impression (clinical global impression of change \\[CGIC\\]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of CGIC was available among the baseline analysis population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '6.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 52', 'description': 'The problems associated with depression-related symptoms experienced during the last 2 weeks were rated by participants ranging from 0 (not at all) to 3 (nearly every day) in total 0 to 27(the higher the more severe) consisting the following 9 items: 1) little interest or pleasure in doing things; 2) depressed, or hopeless; 3) trouble falling or staying asleep, or sleeping too much; 4) feeling tired or having little energy; 5) poor appetite or overeating; 6) feeling bad about yourself - or that you are a failure or have let yourself or your family down; 7) trouble concentrating on things, such as reading the newspaper or watching television; 8) moving or speaking so slowly that other people could have noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual; and 9) thoughts that you would be better off dead, or of hurting yourself. Mean change from baseline in the evaluation score was presented along with standard deviation.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of PHQ-9 was available among the baseline analysis population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Status of EuroQol 5 Dimension (EQ-5D) at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and at Week 52', 'description': 'Health status (EQ-5D) was evaluated based on the following 5 dimensions: mobility, self-care, usual activity (e.g., work, study, housework, family, or leisure activities), pain/discomfort, and anxiety/depression. Each dimension was rated in the three levels of response alternatives "no problems," "some problems," or "extreme problems." For the analysis of EQ-5D, the response outcome for the five dimensions was converted to a utility value using tariff value set based on the Japanese version of EQ-5D. The utility value was not assigned if there was no response in any one of the five dimensions. 1 for full health and 0 for being dead: a positive (negative) number implies that the health state is better (worse) than dead. Mean change from baseline in the evaluation score was presented along with standard deviation.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of EQ-5D was available among the baseline analysis population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fibromyalgia Activity Score (FAS-31) at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '6.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 52', 'description': 'FAS-31 (ranged from 0 to 31) is calculated as the combined score of the widespread pain index (WPI, ranged from 0 to 19) and the symptom severity (SS) scale (ranged from 0 to 12). The WPI is a measure of the number of painful body regions. The SS is the scale of the severity in the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms; ranged from 0 to 3 each) and general physical symptoms (ranged from 0 to 3). WPI ranged from 0 to 19 the higher score indicates more severe of activity, SS ranged from 0-12 also higher score shows more severe symptoms observed. Mean change from baseline in the evaluation score was presented along with standard deviation.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of FAS-31 was available among the baseline analysis population.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Japanese Version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '-15.2', 'spread': '23.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 52', 'description': 'JFIQR is a Japanese version of the Revised Fibromyalgia Impact Questionnaire (FIQR), which was established for overall evaluation of the influence of fibromyalgia on patient\'s health. It consists of three linked sets of domains: "function (9 questions)," "overall impact (2 questions)," and "symptoms (10 questions)." Participants responded to the questions based on an 11-grade scale, ranging from 0 to 10, with 10 being the worst. For the analysis of JFIQR, the score for each domain was modified as follows: The summed score for "function" (ranged from 0 to 90) was divided by 3 and the summed score for "symptoms" (ranged from 0 to 100) was divided by 2. The summed score for "overall impact" (ranged from 0 to 20) was not modified. The total score, the sum of the three modified domain scores (ranged from 0 to 100, the lower score represents a better outcome), was used for the analysis. Mean change from baseline in the evaluation score was presented along with standard deviation.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population for this outcome measure comprised of participants for whom the evaluation outcome of JFIQR was available among the baseline analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '534'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of participants whose survey form were collected and included in analyses is shown.', 'groupId': 'FG000', 'numSubjects': '499'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'No Visit After Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '499', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'LYRICA Capsules (Pregabalin)', 'description': "Participants who received LYRICA Capsules as indicated in the approved local product document were observed for a period of 52 weeks at maximum. The dosage can be adjusted as per physician's discretion."}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<15 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '≥15 and <65 years', 'categories': [{'measurements': [{'value': '392', 'groupId': 'BG000'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '106', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '408', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race and Ethnicity Not Collected', 'categories': [{'measurements': [{'value': '499', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Among 534 participants whose survey form was collected, a total of 35 participants were excluded from the baseline analysis population due to no visit after treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-12-15', 'size': 338303, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-07-23T10:26', 'hasProtocol': True}, {'date': '2018-03-09', 'size': 2469015, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-07-23T10:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 534}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-26', 'studyFirstSubmitDate': '2013-01-18', 'resultsFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-30', 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Drug Reaction', 'timeFrame': 'From Week 1 to 52 weeks at maximum', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Serious Adverse Drug Reaction', 'timeFrame': 'From Week 1 to52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to LYRICA Capsules was assessed by the physician.'}, {'measure': 'Percentage of Participants With Adverse Drug Reaction Unexpected From Japanese Package Insert', 'timeFrame': 'From Week 1 to 52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to LYRICA Capsules was assessed by the physician.'}, {'measure': 'Number of Participants With Adverse Drug Reactions Related to Peripheral Edema or Other Edema-related Events', 'timeFrame': 'From Week 1 to 52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to peripheral edema or other edema-related events was evaluated.'}, {'measure': 'Number of Participants With Adverse Drug Reactions Related to Dizziness, Somnolence, Loss of Consciousness, Syncope, and Potential for Accidental Injury', 'timeFrame': 'From Week 1 to 52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to dizziness, somnolence, loss of consciousness, syncope, and potential for accidental injury was evaluated.'}, {'measure': 'Number of Participants With Adverse Drug Reactions Related to Vision-related Events', 'timeFrame': 'From Week 1 to 52 weeks', 'description': 'An adverse drug reaction (ADR) was any untoward medical occurrence attributed to LYRICA Capsules in a participant who received LYRICA Capsules. Relatedness to LYRICA Capsules was assessed by the physician. Occurrence of ADRs related to vision-related events was evaluated.'}, {'measure': 'Change From Baseline in Pain Score at Week 52', 'timeFrame': 'Baseline and at Week 52', 'description': 'The pain from fibromyalgia experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (no pain) to 10 (the most severe pain possible). Mean change from baseline in the pain score at Week 52 was presented along with standard deviation.'}, {'measure': 'Change From Baseline in Quality of Sleep Score at Week 52', 'timeFrame': 'Baseline and at Week 52', 'description': 'The quality of sleep experienced during the past 24 hours was rated by participants at the time of getting up in the morning on an 11-grade scale, ranging from 0 (the best sleep possible) to 10 (the worst sleep possible). Mean change from baseline in quality of sleep score at Week 52 was presented along with standard deviation.'}, {'measure': "Patient's Impression (PGIC) at Week 52", 'timeFrame': 'At Week 52', 'description': "The patient's impression (patient global impression of change \\[PGIC\\]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by participants on a 7-grade scale."}, {'measure': "Physician's Impression (CGIC) at Week 52", 'timeFrame': 'At Week 52', 'description': "The physician's impression (clinical global impression of change \\[CGIC\\]) at Week 52, as compared to the baseline condition (including the first day of treatment), was rated by the physician on a 7-grade scale."}, {'measure': 'Change From Baseline in Patient Health Questionnaire (PHQ-9) Score at Week 52', 'timeFrame': 'Baseline and at Week 52', 'description': 'The problems associated with depression-related symptoms experienced during the last 2 weeks were rated by participants ranging from 0 (not at all) to 3 (nearly every day) in total 0 to 27(the higher the more severe) consisting the following 9 items: 1) little interest or pleasure in doing things; 2) depressed, or hopeless; 3) trouble falling or staying asleep, or sleeping too much; 4) feeling tired or having little energy; 5) poor appetite or overeating; 6) feeling bad about yourself - or that you are a failure or have let yourself or your family down; 7) trouble concentrating on things, such as reading the newspaper or watching television; 8) moving or speaking so slowly that other people could have noticed. Or the opposite - being so fidgety or restless that you have been moving around a lot more than usual; and 9) thoughts that you would be better off dead, or of hurting yourself. Mean change from baseline in the evaluation score was presented along with standard deviation.'}, {'measure': 'Change From Baseline in Health Status of EuroQol 5 Dimension (EQ-5D) at 52 Weeks', 'timeFrame': 'Baseline and at Week 52', 'description': 'Health status (EQ-5D) was evaluated based on the following 5 dimensions: mobility, self-care, usual activity (e.g., work, study, housework, family, or leisure activities), pain/discomfort, and anxiety/depression. Each dimension was rated in the three levels of response alternatives "no problems," "some problems," or "extreme problems." For the analysis of EQ-5D, the response outcome for the five dimensions was converted to a utility value using tariff value set based on the Japanese version of EQ-5D. The utility value was not assigned if there was no response in any one of the five dimensions. 1 for full health and 0 for being dead: a positive (negative) number implies that the health state is better (worse) than dead. Mean change from baseline in the evaluation score was presented along with standard deviation.'}, {'measure': 'Change From Baseline in Fibromyalgia Activity Score (FAS-31) at 52 Weeks', 'timeFrame': 'At Week 52', 'description': 'FAS-31 (ranged from 0 to 31) is calculated as the combined score of the widespread pain index (WPI, ranged from 0 to 19) and the symptom severity (SS) scale (ranged from 0 to 12). The WPI is a measure of the number of painful body regions. The SS is the scale of the severity in the three symptoms (fatigue, waking unrefreshed, and cognitive symptoms; ranged from 0 to 3 each) and general physical symptoms (ranged from 0 to 3). WPI ranged from 0 to 19 the higher score indicates more severe of activity, SS ranged from 0-12 also higher score shows more severe symptoms observed. Mean change from baseline in the evaluation score was presented along with standard deviation.'}, {'measure': 'Change From Baseline in the Japanese Version of the Revised Fibromyalgia Impact Questionnaire (JFIQR) at 52 Weeks', 'timeFrame': 'At Week 52', 'description': 'JFIQR is a Japanese version of the Revised Fibromyalgia Impact Questionnaire (FIQR), which was established for overall evaluation of the influence of fibromyalgia on patient\'s health. It consists of three linked sets of domains: "function (9 questions)," "overall impact (2 questions)," and "symptoms (10 questions)." Participants responded to the questions based on an 11-grade scale, ranging from 0 to 10, with 10 being the worst. For the analysis of JFIQR, the score for each domain was modified as follows: The summed score for "function" (ranged from 0 to 90) was divided by 3 and the summed score for "symptoms" (ranged from 0 to 100) was divided by 2. The summed score for "overall impact" (ranged from 0 to 20) was not modified. The total score, the sum of the three modified domain scores (ranged from 0 to 100, the lower score represents a better outcome), was used for the analysis. Mean change from baseline in the evaluation score was presented along with standard deviation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lyrica', 'pregabalin', 'Good post marketing practice', 'Post Marketing Surveillance', 'Regulatory Post Marketing Commitment Plan', 'Fibromyalgia'], 'conditions': ['Pain Associated With Fibromyalgia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081282&StudyName=Special%20Investigation%20of%20Pregabalin%20for%20Fibromyalgia%20%28Regulatory%20Post%20Marketing%20Commitment%20Plan%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.', 'detailedDescription': 'All the patients whom an investigator prescribes the first pregabalin should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care clinic and hospital for Fibromyalgia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Fibromyalgia\n* Pregabalin naive patient\n\nExclusion Criteria:\n\n* Clinical diagnosis of neuropathic pain'}, 'identificationModule': {'nctId': 'NCT01773993', 'briefTitle': 'Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'SPECIAL INVESTIGATION OF PREGABALIN FOR FIBROMYALGIA', 'orgStudyIdInfo': {'id': 'A0081282'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregabalin', 'description': 'Subjects who are treated with pregabalin', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Pregabalin', 'type': 'DRUG', 'otherNames': ['Lyrica® Capsules 25 mg, Lyrica® Capsules 75 mg, Lyrica® Capsules 150 mg'], 'description': 'The usual adult dosage for oral use begins at 150 mg/day of pregabalin twice daily, and should be gradually increased to 300 mg/day over 1 week or more and then maintained at 300-450 mg/day as needed. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 450 mg, and should be orally administered twice daily.', 'armGroupLabels': ['Pregabalin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}