Viewing Study NCT01124604

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Ignite Creation Date: 2025-12-24 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
Study NCT ID: NCT01124604
Status: COMPLETED
Last Update Posted: 2013-05-14
First Post: 2010-04-22
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants
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': 'D010146', 'term': 'Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077432', 'term': 'Tapentadol'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+81-3-4411-5509', 'title': 'Manager', 'organization': 'Neuroscience Department, Clinical Science Department, R&D in Janssen Japan Chiyodaku, Tokyo 101-0065 Japan'}, 'certainAgreement': {'otherDetails': 'The disclosure restriction on PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the sponsor requires.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 30 days post last study dose', 'eventGroups': [{'id': 'EG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.", 'otherNumAtRisk': 60, 'otherNumAffected': 54, 'seriousNumAtRisk': 60, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.", 'otherNumAtRisk': 31, 'otherNumAffected': 24, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Electrocardiogram T wave inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Eosinophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Neutrophil count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Respiratory rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Protein urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Renal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Contrast media allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Yawning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}], 'seriousEvents': [{'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.9', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.12', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '0.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.46', 'estimateComment': 'Test for no difference between treatments was derived from Analysis of covariance (ANCOVA) model with factors treatment, disease and Baseline pain intensity as covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. Last observation carried forward (LOCF) method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 11-point Numerical Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Change at Week 1', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.08', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.55', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 5', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '1.82', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 7', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.01', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 8', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 9', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 10', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.98', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 11', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-2.9', 'spread': '2.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11', 'description': 'Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. LOCF method was used to impute missing values.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Greater than or equal to 30 percent improvement', 'categories': [{'measurements': [{'value': '55.0', 'spread': '1.17', 'groupId': 'OG000', 'lowerLimit': '41.61', 'upperLimit': '67.88'}, {'value': '61.3', 'spread': '1.12', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}]}]}, {'title': 'Greater than or equal to 50 percent improvement', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '27.56', 'upperLimit': '53.46'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '30.15', 'upperLimit': '66.94'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data.'}, {'type': 'SECONDARY', 'title': "Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Week 8; Very Much Improved (n = 47, 29)', 'categories': [{'measurements': [{'value': '13', 'spread': '1.17', 'groupId': 'OG000', 'lowerLimit': '41.61', 'upperLimit': '67.88'}, {'value': '5', 'spread': '1.12', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}]}]}, {'title': 'Week 8; Much Improved (n = 47, 29)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '27.56', 'upperLimit': '53.46'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '30.15', 'upperLimit': '66.94'}]}]}, {'title': 'Week 8; Minimally Improved (n = 47, 29)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; No Change (n = 47, 29)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; Minimally Worse (n = 47, 29)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; Much Worse (n = 47, 29)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Very Much Improved (n = 45, 29)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Much Improved (n = 45, 29)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Minimally Improved (n = 45, 29)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; No Change (n = 45, 29)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 ; Minimally Worse (n = 45, 29)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Much Worse (n = 45, 29)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8, Week 12', 'description': 'The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': "Number of Participants With Response Based on Physician's Global Assessment Scale", 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Week 8; Effective (n=47, 29)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; Not effective (n=47, 29)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Effective (n=45, 29)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Not effective (n=45, 29)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8, Week 12', 'description': 'Physician\'s Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "not effective".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all participants who received study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Baseline (n=60,31)', 'categories': [{'measurements': [{'value': '46', 'spread': '1.17', 'groupId': 'OG000', 'lowerLimit': '41.61', 'upperLimit': '67.88'}, {'value': '25', 'spread': '1.12', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}]}]}, {'title': 'Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: "Do you have any pain today other than everyday kinds of pain?" on a 2-point scale of "yes" or "no".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '9', 'spread': '1.17', 'groupId': 'OG000', 'lowerLimit': '41.61', 'upperLimit': '67.88'}, {'value': '7', 'spread': '1.12', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}]}]}, {'title': 'Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Total Score; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Total Score; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '41.06', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '31.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Sleep Latency was addressed by the question: "How long after bedtime/lights out did you fall asleep last night?" and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '1.50', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'Time slept was addressed by the question: "How long did you sleep last night?" and the change from Baseline in time slept was reported.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Awakenings Based on Sleep Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Baseline; 0 awakening (n=60,31)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '41.61', 'upperLimit': '67.88'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}]}]}, {'title': 'Baseline; 1 awakening (n=60,31)', 'categories': [{'measurements': [{'value': '18', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '6', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Baseline; 2 awakenings (n=60,31)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Baseline; 3 awakenings (n=60,31)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline; 4 awakenings (n=60,31)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline; >= 5 awakenings (n=60,31)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; 0 awakening (n=45,29)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; 1 awakening (n=45,29)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; 2 awakenings (n=45,29)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; 3 awakenings (n=45,29)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; 4 awakenings (n=45,29)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; >=5 awakenings (n=45,29)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'Number of awakenings was addressed by the question: "How many times did you wake up during the night?\'\' and lesser number signified better sleep.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response Based on Overall Quality of Sleep Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Baseline; Excellent (n=60, 31)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '41.61', 'upperLimit': '67.88'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}]}]}, {'title': 'Baseline; Good (n=60, 31)', 'categories': [{'measurements': [{'value': '37', 'spread': '1.55', 'groupId': 'OG000'}, {'value': '17', 'spread': '1.00', 'groupId': 'OG001'}]}]}, {'title': 'Baseline; Fair (n=60, 31)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Baseline; Poor (n=60, 31)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Excellent (n=45, 29)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Good (n=45, 29)', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Fair (n=45, 29)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; Poor (n=45, 29)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 12', 'description': 'Overall quality of sleep was addressed by the question: "Please rate the overall quality of your sleep last night" and participants could choose one of the following options: excellent, good, fair or poor.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Physical Functioning; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '48.9', 'spread': '18.18', 'groupId': 'OG000', 'lowerLimit': '41.61', 'upperLimit': '67.88'}, {'value': '51.9', 'spread': '24.65', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}]}]}, {'title': 'Physical Functioning; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '12.1', 'spread': '18.01', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '16.26', 'groupId': 'OG001'}]}]}, {'title': 'Role-Physical; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '57.8', 'spread': '27.46', 'groupId': 'OG000'}, {'value': '57.1', 'spread': '26.41', 'groupId': 'OG001'}]}]}, {'title': 'Role-Physical; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '9.6', 'spread': '30.05', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '32.13', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '34.7', 'spread': '15.53', 'groupId': 'OG000'}, {'value': '34.3', 'spread': '14.80', 'groupId': 'OG001'}]}]}, {'title': 'Bodily Pain; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '19.4', 'spread': '20.91', 'groupId': 'OG000'}, {'value': '15.1', 'spread': '19.89', 'groupId': 'OG001'}]}]}, {'title': 'General Health; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '47.6', 'spread': '15.14', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '18.13', 'groupId': 'OG001'}]}]}, {'title': 'General Health; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '13.81', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '14.18', 'groupId': 'OG001'}]}]}, {'title': 'Vitality; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '46.4', 'spread': '21.54', 'groupId': 'OG000'}, {'value': '51.4', 'spread': '16.67', 'groupId': 'OG001'}]}]}, {'title': 'Vitality; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '7.6', 'spread': '16.20', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '17.56', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '66.5', 'spread': '26.29', 'groupId': 'OG000'}, {'value': '66.1', 'spread': '23.09', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '12.5', 'spread': '21.65', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '32.13', 'groupId': 'OG001'}]}]}, {'title': 'Role-Emotional; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '63.6', 'spread': '28.29', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '28.25', 'groupId': 'OG001'}]}]}, {'title': 'Role-Emotional; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '10.7', 'spread': '25.23', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '31.58', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '58.7', 'spread': '22.17', 'groupId': 'OG000'}, {'value': '59.7', 'spread': '20.08', 'groupId': 'OG001'}]}]}, {'title': 'Mental Health; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '7.4', 'spread': '20.16', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '19.08', 'groupId': 'OG001'}]}]}, {'title': 'Mental Summary; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '47.5', 'spread': '10.60', 'groupId': 'OG000'}, {'value': '48.6', 'spread': '9.99', 'groupId': 'OG001'}]}]}, {'title': 'Mental Summary; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '3.6', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '8.71', 'groupId': 'OG001'}]}]}, {'title': 'Physical Summary; Baseline (n=60, 31)', 'categories': [{'measurements': [{'value': '25.5', 'spread': '13.60', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '16.75', 'groupId': 'OG001'}]}]}, {'title': 'Physical Summary; Change at Week 12 (n=45, 29)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '12.78', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '15.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Global Score; Baseline (n=27, 13)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.64', 'groupId': 'OG001'}]}]}, {'title': 'Global Score; Change at Week 12 (n=20, 13)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Baseline (n=33, 18)', 'categories': [{'measurements': [{'value': '11.7', 'spread': '5.08', 'groupId': 'OG000'}, {'value': '12.7', 'spread': '5.35', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12 (n=25, 16)', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '4.25', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as "Yes"/"No" where "Yes" is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomly assigned participants who received at least 1 dose of study drug and had post-randomization efficacy data. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'No Withdrawal', 'categories': [{'measurements': [{'value': '60', 'spread': '1.17', 'groupId': 'OG000', 'lowerLimit': '41.61', 'upperLimit': '67.88'}, {'value': '31', 'spread': '1.12', 'groupId': 'OG001', 'lowerLimit': '42.19', 'upperLimit': '78.15'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderately Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe Withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all the participants who received at least 1 dose of the study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Concentration of Tapentadol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'classes': [{'title': 'Tapentadol Hydrochloride 25 mg Week 2, n=11', 'categories': [{'measurements': [{'value': '14.1', 'spread': '6.02', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 50 mg Week 2, n=48', 'categories': [{'measurements': [{'value': '29.7', 'spread': '17.1', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 100 mg Week 2, n=1', 'categories': [{'measurements': [{'value': '47.9', 'spread': 'NA', 'comment': 'Standard deviation was not estimable as only 1 participant was evaluable at given time point.', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 150 mg Week 2, n=0', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participant was evaluable for this dose at given time point.', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 200 mg Week 2, n=0', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participant was evaluable for this dose at given time point.', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 250 mg Week 2, n=0', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participant was evaluable for this dose at given time point.', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 25 mg Week 4, n=4', 'categories': [{'measurements': [{'value': '22.8', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 50 mg Week 4, n=10', 'categories': [{'measurements': [{'value': '23.6', 'spread': '6.20', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 100 mg Week 4, n=28', 'categories': [{'measurements': [{'value': '59.0', 'spread': '42.7', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 150 mg Week 4, n=16', 'categories': [{'measurements': [{'value': '76.2', 'spread': '48.5', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 200 mg Week 4, n=0', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participant was evaluable for this dose at given time point.', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 250 mg Week 4, n=0', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not analyzed as no participant was evaluable for this dose at given time point.', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 25 mg Week 8, n=3', 'categories': [{'measurements': [{'value': '25.1', 'spread': '15.3', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 50 mg Week 8, n=8', 'categories': [{'measurements': [{'value': '22.7', 'spread': '12.2', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 100 mg Week 8, n=16', 'categories': [{'measurements': [{'value': '57.7', 'spread': '40.7', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 150 mg Week 8, n=13', 'categories': [{'measurements': [{'value': '83.2', 'spread': '35.9', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 200 mg Week 8, n=4', 'categories': [{'measurements': [{'value': '87.8', 'spread': '58.9', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 250 mg Week 8, n=4', 'categories': [{'measurements': [{'value': '147', 'spread': '119', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 25 mg Week 12, n=3', 'categories': [{'measurements': [{'value': '29.2', 'spread': '13.2', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 50 mg Week 12, n=8', 'categories': [{'measurements': [{'value': '25.1', 'spread': '8.17', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 100 mg Week 12, n=14', 'categories': [{'measurements': [{'value': '49.1', 'spread': '36.3', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 150 mg Week 12, n=12', 'categories': [{'measurements': [{'value': '40.4', 'spread': '33.9', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 200 mg Week 12, n=4', 'categories': [{'measurements': [{'value': '119', 'spread': '165', 'groupId': 'OG000'}]}]}, {'title': 'Tapentadol Hydrochloride 250 mg Week 12, n=4', 'categories': [{'measurements': [{'value': '130', 'spread': '77.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 2, 4, 8, 12', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least 1 serum study drug concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'FG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tapentadol Hydrochloride', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'BG001', 'title': 'Placebo', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '15.54', 'groupId': 'BG000'}, {'value': '68.1', 'spread': '13.73', 'groupId': 'BG001'}, {'value': '65.1', 'spread': '15.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-10', 'studyFirstSubmitDate': '2010-04-22', 'resultsFirstSubmitDate': '2013-03-06', 'studyFirstSubmitQcDate': '2010-05-13', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-03-06', 'studyFirstPostDateStruct': {'date': '2010-05-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Response Based on Clinical Opioid Withdrawal Symptoms Questionnaire (COWS)', 'timeFrame': 'Week 12', 'description': 'COWS is an 11-item questionnaire for clinical assessment of withdrawal symptoms. Total score is calculated by adding the scores of all the 11-items. The severity of withdrawal symptoms is categorized using values of total score as: 0-4 = no withdrawal, 5-12 = mild, 13-24 = moderate, 25-36 = moderately severe, and 37-48 = severe withdrawal.'}, {'measure': 'Serum Concentration of Tapentadol', 'timeFrame': 'Week 2, 4, 8, 12'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in 11-point Numerical Rating Scale (NRS) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 11-point Numerical Rating Scale (NRS)', 'timeFrame': 'Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11', 'description': 'Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale. The mean pain intensity during the past 74 hours (3 days) was evaluated at Baseline and the mean pain intensity during the past 12 hours was evaluated at subsequent study visits.'}, {'measure': 'Percentage of Participants With Response Based on 11-point Numerical Rating Scale (NRS)', 'timeFrame': 'Week 12', 'description': 'Percentage of participants with improvement in mean NRS score by greater than or equal to 30 percent or 50 percent in the last week from Baseline were considered as responders. Participants were asked to assess the average pain intensity on a 11-point NRS ranging from 0 (no pain) to 10 (maximum pain imaginable) by selecting a number applicable to their pain on the scale.'}, {'measure': "Number of Participants With Categorical Scores on Patient's Global Impression of Change (PGIC) Scale", 'timeFrame': 'Week 8, Week 12', 'description': 'The PGIC is a 7-point scale that requires the participants to assess how much their illness has improved or worsened relative to a Baseline state at the beginning of the intervention. The response options are 1 = very much improved, 2 = much improved, 3 = minimally improve, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.'}, {'measure': "Number of Participants With Response Based on Physician's Global Assessment Scale", 'timeFrame': 'Week 8, Week 12', 'description': 'Physician\'s Global Assessment Scale assesses the therapeutic efficacy (effectiveness) of the study drug for pain control on a 2-point scale of "effective" and "not effective".'}, {'measure': 'Number of Participants With Presence of Pain Based on Brief Pain Inventory-Short Form (BPI-sf) Scale', 'timeFrame': 'Baseline, Week 12', 'description': 'BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 1 for presence of pain assesses the question: "Do you have any pain today other than everyday kinds of pain?" on a 2-point scale of "yes" or "no".'}, {'measure': 'Number of Participants With 50 Percent Pain Relief Based on Brief Pain Inventory-Short Form (BPI-sf) Scale', 'timeFrame': 'Baseline, Week 12', 'description': 'BPI-sf is a self-evaluated pain assessment form consisting of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Item 8 for efficacy of pain treatment assesses number of participants with at least 50 percent pain relief during the last 24 hours on a scale ranging from 0 percent (no relief) to 100 percent (complete relief).'}, {'measure': 'Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Total Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'BPI-sf consists of 15 items (item 1 - presence of pain, item 2 - pain location, items 3 to 6 - pain severity, item 7 - status of pain treatment, item 8 - efficacy of pain treatment, and items 9a to 9g - interference of pain with daily life). Total score is defined as the mean scores from items 3, 4, 5, 6 and 9 recorded on an 11-point scale where 0 = no pain and 10 = pain as bad as you can imagine. Negative change indicates an improvement in pain.'}, {'measure': 'Change From Baseline in Sleep Latency Based on Sleep Questionnaire at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Sleep Latency was addressed by the question: "How long after bedtime/lights out did you fall asleep last night?" and the change from Baseline in sleep latency was reported. Decrease in time indicated improvement.'}, {'measure': 'Change From Baseline in Time Slept Based on Sleep Questionnaire at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'Time slept was addressed by the question: "How long did you sleep last night?" and the change from Baseline in time slept was reported.'}, {'measure': 'Number of Participants With Awakenings Based on Sleep Questionnaire', 'timeFrame': 'Baseline, Week 12', 'description': 'Number of awakenings was addressed by the question: "How many times did you wake up during the night?\'\' and lesser number signified better sleep.'}, {'measure': 'Number of Participants With Response Based on Overall Quality of Sleep Questionnaire', 'timeFrame': 'Baseline, Week 12', 'description': 'Overall quality of sleep was addressed by the question: "Please rate the overall quality of your sleep last night" and participants could choose one of the following options: excellent, good, fair or poor.'}, {'measure': 'Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Scores at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state.'}, {'measure': 'Change From Baseline in Western Ontario MacMaster Questionnaire (WOMAC) Global Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'WOMAC is a self administered 24-item questionnaire used to evaluate participants with osteoarthritis of the knee. It consists of 3 subscales: pain (5 items), joint stiffness (2 items), and physical function (17 items). Each item is assessed on a 5-point scale from 0 to 4. The global score assesses pain, disability and joint stiffness and ranges from 0 to 96. Higher scores indicate that a symptom is bothersome and physically disabling.'}, {'measure': 'Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'RDQ scale is used to assess the impact of low back pain on daily activities by participants. The scale consists of 24 item questionnaire with options as "Yes"/"No" where "Yes" is counted as 1 point. The total score ranged from 0 to 24, with higher scores indicating greater disability.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Low Back Pain', 'Back Pain', 'Osteoarthritis, Knee', 'Tapentadol', 'Tapentadol Hydrochloride Extended Release'], 'conditions': ['Pain', 'Low Back Pain', 'Back Pain', 'Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.', 'detailedDescription': "This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), parallel-group (each group of participants will be treated at the same time) comparison study in participants with chronic pain due to osteoarthritis of knee or low back pain. The study duration will be of 14 weeks, which consists of a screening period of 1 week during which the participants will be evaluated for study eligibility, a treatment period of 12 weeks and a follow-up period of 1 week. The treatment period will consist of titration period (from the initiation of the study treatment to determination of the individual's maintenance dose) and maintenance period (from completion of the titration period to the completion of the treatment period). An optimal dose (maintenance dose) will be determined for each participant during the titration period and the treatment will be continued at the maintenance dose to assess the efficacy and safety. Tapentadol hydrochloride ER tablets 25 to 250 milligram or placebo will be administered orally twice daily. Efficacy and safety of the participants will primarily be evaluated by change from baseline in average pain intensity score based on 11-point Numerical Rating Scale (NRS) and Clinical Opiate Withdrawal Scale (COWS), respectively. Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with chronic pain due to osteoarthritis of knee or low back pain continuing for at least 12 weeks before informed consent\n* Participants who did not achieve adequate analgesia (pain control) with routine treatment with an oral non-opioid analgesic (drug used to control pain) at its usual upper-limit dose or at an adequate fixed dose for at least 14 consecutive days during the 12 weeks before informed consent\n* Participants who have not experienced treatment with conventional opioids, except for short term use of opioid analgesics for treatment of post-operative acute pain more than 30 days before consent or temporary use of codeine phosphate or dihydrocodeine phosphate for purposes other than pain relief (e.g. for antitussive) more than 2 days before informed consent\n* Participants with average pain intensity score of greater than or equal to 5 on an 11-point Numerical Rating Scale (NRS) during 48 hours before informed consent and are considered requiring opioid treatment by the Investigator\n* Participants who are able to visit the medical institutions throughout the study period\n\nExclusion Criteria:\n\n* Participants who are taking a monoamine oxidase inhibitor within 14 days before informed consent\n* Participants with current or a history of epilepsy or seizure disorders\n* Participants suspected with intracranial hypertension (e.g. traumatic encephalopathy)\n* Participants with uncontrolled or clinically significant arrhythmia (irregular heart rate)\n* Participants with moderate to severe liver dysfunction or severe renal dysfunction'}, 'identificationModule': {'nctId': 'NCT01124604', 'briefTitle': 'An Efficacy and Safety Study for Tapentadol Extended Release (JNS024ER) in Chronic Pain Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutical K.K.'}, 'officialTitle': 'Phase II Study of JNS024ER in Japanese Subjects With Chronic Pain Due to Osteoarthritis of the Knee or Low Back Pain', 'orgStudyIdInfo': {'id': 'CR016999'}, 'secondaryIdInfos': [{'id': 'JNS024ER-JPN-N21', 'type': 'OTHER', 'domain': 'Janssen Pharmaceutical K.K., Japan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tapentadol Hydrochloride', 'interventionNames': ['Drug: Tapentadol Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tapentadol Hydrochloride', 'type': 'DRUG', 'description': "Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.", 'armGroupLabels': ['Tapentadol Hydrochloride']}, {'name': 'Placebo', 'type': 'DRUG', 'description': "Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.", 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aichi', 'country': 'Japan', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'city': 'Amagasaki', 'country': 'Japan', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Chikushi', 'country': 'Japan', 'geoPoint': {'lat': 33.56055, 'lon': 130.78718}}, {'city': 'Edogawa City', 'country': 'Japan', 'geoPoint': {'lat': 35.69225, 'lon': 139.87308}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Fukushima', 'country': 'Japan', 'geoPoint': {'lat': 37.75, 'lon': 140.46667}}, {'city': 'Hiratsuka', 'country': 'Japan', 'geoPoint': {'lat': 35.32785, 'lon': 139.33735}}, {'city': 'Kawasaki', 'country': 'Japan', 'geoPoint': {'lat': 35.52056, 'lon': 139.71722}}, {'city': 'Kōtō City', 'country': 'Japan', 'geoPoint': {'lat': 32.77856, 'lon': 130.74537}}, {'city': 'Matsudo', 'country': 'Japan', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'city': 'Meguro City', 'country': 'Japan', 'geoPoint': {'lat': 35.6322, 'lon': 139.70174}}, {'city': 'Minatoku', 'country': 'Japan', 'geoPoint': {'lat': 32.57237, 'lon': 130.59341}}, {'city': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Sagamihara', 'country': 'Japan', 'geoPoint': {'lat': 35.56707, 'lon': 139.24167}}, {'city': 'Shibuya City', 'country': 'Japan', 'geoPoint': {'lat': 35.6589, 'lon': 139.70665}}, {'city': 'Shinjuku-Ku', 'country': 'Japan'}, {'city': 'Toshima-Ku', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Janssen Pharmaceutical K.K. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutical K.K.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutical K.K.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}