Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-27 @ 7:55 PM
Study NCT ID:
NCT00472303
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2007-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands', 'Serbia and Montenegro', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072716', 'term': 'Cancer Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': {'email': 'Clinical-Trials@grunenthal.com', 'phone': '+49 241 569 3223', 'title': 'Director of Clinical Trials', 'organization': 'Grünenthal GmbH'}, 'certainAgreement': {'otherDetails': 'The Sponsor reserves the right to review any publication pertaining to the trial at least 30 days before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events reported any time after treatment is taken, to within 30 days after end of treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Tapentadol Prolonged Release (Titration Phase)', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.', 'otherNumAtRisk': 338, 'otherNumAffected': 112, 'seriousNumAtRisk': 338, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Morphine Controlled Release (Titration Phase)', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.', 'otherNumAtRisk': 158, 'otherNumAffected': 80, 'seriousNumAtRisk': 158, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Tapentadol Prolonged Release (Maintenance Phase)', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. The participant continued at the dose that was effective at the end of the Titration Phase.', 'otherNumAtRisk': 106, 'otherNumAffected': 41, 'seriousNumAtRisk': 106, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.', 'otherNumAtRisk': 112, 'otherNumAffected': 34, 'seriousNumAtRisk': 112, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Morphine Controlled Release (Maintenance Phase)', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. The dose that was effective at the end of the Titration Phase.', 'otherNumAtRisk': 109, 'otherNumAffected': 37, 'seriousNumAtRisk': 109, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tumour pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hospitalization due to travel problems', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cor pulmonale acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Adrenocortical insufficiency acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Female genital tract fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 338, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 112, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 109, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Scored as Responder in Maintenance Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release (Maintenance Phase)', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release (Maintenance Phase)', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 18 through Day 43 (End of Maintenance Phase)', 'description': 'A "responder" is a participant in the study that:\n\n1. completed 28 days of the maintenance phase\n2. had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.\n3. did not use more than 20 mg of rescue medication per day on average in the 28 day maintenance period (from Day 18 to Day 43).\n\nA participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that failed to meet only 1 of the 3 criteria is not counted as a responder.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Maintenance Phase).'}, {'type': 'SECONDARY', 'title': 'Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'title': 'Prior to start of the Titration Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.315', 'spread': '1.4435', 'groupId': 'OG000'}]}]}, {'title': 'End of Week 1 of the Titration Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '329', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.324', 'spread': '1.7476', 'groupId': 'OG000'}]}]}, {'title': 'End of Week 2 of the Titration Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.021', 'spread': '1.6872', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'Participants were asked to record their "average pain over the last 24 hours" pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Titration Period), observed.'}, {'type': 'SECONDARY', 'title': 'Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'title': 'Prior to start of the Titration Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.162', 'spread': '1.5693', 'groupId': 'OG000'}]}]}, {'title': 'End of Week 1 of the Titration Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.906', 'spread': '1.9039', 'groupId': 'OG000'}]}]}, {'title': 'End of Week 2 of the Titration Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.669', 'spread': '1.7851', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'Participants were asked to record their "average pain over the last 24 hours" pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Titration Period), observed.'}, {'type': 'SECONDARY', 'title': 'Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release (Maintenance Phase)', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Matching Placebo After Tapentadol in the Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}, {'id': 'OG002', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}], 'classes': [{'title': 'Prior to start of Maintenance Phase', 'categories': [{'measurements': [{'value': '3.198', 'spread': '1.2043', 'groupId': 'OG000'}, {'value': '2.928', 'spread': '1.2353', 'groupId': 'OG001'}, {'value': '2.928', 'spread': '1.4106', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 1 of the Maintenance Phase', 'categories': [{'measurements': [{'value': '3.220', 'spread': '1.2385', 'groupId': 'OG000'}, {'value': '3.115', 'spread': '1.3799', 'groupId': 'OG001'}, {'value': '2.903', 'spread': '1.4645', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 2 of the Maintenance Phase', 'categories': [{'measurements': [{'value': '3.248', 'spread': '1.3724', 'groupId': 'OG000'}, {'value': '3.005', 'spread': '1.5723', 'groupId': 'OG001'}, {'value': '2.858', 'spread': '1.4783', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 3 of the Maintenance Phase', 'categories': [{'measurements': [{'value': '3.129', 'spread': '1.3267', 'groupId': 'OG000'}, {'value': '3.055', 'spread': '1.6702', 'groupId': 'OG001'}, {'value': '2.775', 'spread': '1.4312', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 4 of the Maintenance Phase', 'categories': [{'measurements': [{'value': '3.121', 'spread': '1.3768', 'groupId': 'OG000'}, {'value': '3.095', 'spread': '1.7349', 'groupId': 'OG001'}, {'value': '2.768', 'spread': '1.5065', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 18 through Day 43 (End of Maintenance Phase)', 'description': 'Participants were asked to record their "average pain over the last 24 hours" pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Maintenance Period). Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release (Titration Phase)', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'title': 'Start of Titration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.344', 'spread': '1.4568', 'groupId': 'OG000'}]}]}, {'title': 'End of Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.326', 'spread': '1.7650', 'groupId': 'OG000'}]}]}, {'title': 'End of Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.049', 'spread': '1.8015', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Titration Phase), observed.'}, {'type': 'SECONDARY', 'title': 'Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Morphine Controlled Release (Titration Phase)', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'title': 'Start of Titration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.258', 'spread': '1.5609', 'groupId': 'OG000'}]}]}, {'title': 'End of Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.937', 'spread': '1.9080', 'groupId': 'OG000'}]}]}, {'title': 'End of Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.690', 'spread': '1.8365', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Observed, i.e. participants contributing data via their electronic diary.'}, {'type': 'SECONDARY', 'title': 'Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release (Maintenance Phase)', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Matching Placebo After Tapentadol in the Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}, {'id': 'OG002', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}], 'classes': [{'title': 'Prior to start of maintenance phase', 'categories': [{'measurements': [{'value': '3.1444', 'spread': '1.16485', 'groupId': 'OG000'}, {'value': '2.8686', 'spread': '1.19387', 'groupId': 'OG001'}, {'value': '2.832', 'spread': '1.3895', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 1', 'categories': [{'measurements': [{'value': '3.0869', 'spread': '1.22550', 'groupId': 'OG000'}, {'value': '3.0073', 'spread': '1.32110', 'groupId': 'OG001'}, {'value': '2.780', 'spread': '1.3706', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 2', 'categories': [{'measurements': [{'value': '3.1148', 'spread': '1.27905', 'groupId': 'OG000'}, {'value': '2.8683', 'spread': '1.47838', 'groupId': 'OG001'}, {'value': '2.790', 'spread': '1.4170', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 3', 'categories': [{'measurements': [{'value': '3.0137', 'spread': '1.26515', 'groupId': 'OG000'}, {'value': '2.9122', 'spread': '1.60299', 'groupId': 'OG001'}, {'value': '2.733', 'spread': '1.4512', 'groupId': 'OG002'}]}]}, {'title': 'End of Week 4', 'categories': [{'measurements': [{'value': '3.0002', 'spread': '1.37551', 'groupId': 'OG000'}, {'value': '2.9220', 'spread': '1.68601', 'groupId': 'OG001'}, {'value': '2.728', 'spread': '1.4481', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 through Day 43 (End of Maintenance Phase)', 'description': 'Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the 3 days prior to re-randomization or during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Maintenance Period). Last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Use of Rescue Medication in the Titration Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the titration phase were counted. This data was captured in an electronic diary.\n\nDuring the trial, morphine immediate release 10 mg was allowed as required without a maximum dose defined. However, participants were only re-randomized if their mean consumption of rescue medication was less or equal to 2 doses (20 mg) per day during the last 3 days of the titration phase).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Titration phase), observed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15 through Day 43 (End of Maintenance Phase)', 'description': "Participants were issued morphine 10 mg immediate release medication. The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the maintenance phase were counted. This use of morphine immediate release was captured in each participant's electronic diary.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Maintenance phase), observed.'}, {'type': 'SECONDARY', 'title': 'The Average Mean Total Daily Dose of Rescue Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}, {'value': '111', 'groupId': 'OG003'}, {'value': '109', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release (Titration Phase)', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release Titration Phase', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses'}, {'id': 'OG002', 'title': 'Tapentadol Prolonged Release (Maintenance Phase)', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG003', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily in the titration phase. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).'}, {'id': 'OG004', 'title': 'Morphine Controlled Release Maintenance Phase', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.31', 'spread': '17.41', 'groupId': 'OG000'}, {'value': '8.87', 'spread': '12.50', 'groupId': 'OG001'}, {'value': '11.2', 'spread': '12.739', 'groupId': 'OG002'}, {'value': '13.65', 'spread': '13.666', 'groupId': 'OG003'}, {'value': '8.91', 'spread': '14.951', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Start of Titration Phase) through Day 43 (End of Maintenance Phase)', 'description': 'Mean total daily dose of rescue medication morphine sulphate immediate release tablets in milligrams per day (mg/day).', 'unitOfMeasure': 'milligrams per day of morphine rescue', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set for each phase of the trial, observed.'}, {'type': 'SECONDARY', 'title': 'Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'title': 'Mental Component Summary', 'categories': [{'measurements': [{'value': '1.3', 'spread': '10.63', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '11.78', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Summary', 'categories': [{'measurements': [{'value': '2.0', 'spread': '5.99', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '6.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (End of Titration Phase)', 'description': 'The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (Titration Period), observed. Start of Titration and Endpoint Titration observations.'}, {'type': 'SECONDARY', 'title': 'Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Extended Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'title': 'Mental Component Summary', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '10.81', 'groupId': 'OG000'}, {'value': '-2.164', 'spread': '9.42', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '9.99', 'groupId': 'OG002'}]}]}, {'title': 'Physical Component Summary', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '6.26', 'groupId': 'OG000'}, {'value': '-0.671', 'spread': '7.21', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '6.29', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.'}, {'type': 'SECONDARY', 'title': 'Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.093', 'spread': '0.3294', 'groupId': 'OG000'}, {'value': '0.131', 'spread': '0.3162', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (End of Titration Phase)', 'description': 'The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).\n\nThe responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. A positive change in the mean indicates that during this phase the health status improved. A positive change indicates an improvement in health. The minimal important difference is 0.074 (range -0.011 to 0.140).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (Titration Phase), observed.'}, {'type': 'SECONDARY', 'title': 'Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '22.63', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '20.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (End of Titration Phase)', 'description': 'EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate better health. The values indicated represent the change from Day 1, a positive value indicates an improvement since the start of treatment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (Titration Phase), observed.'}, {'type': 'SECONDARY', 'title': 'Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0626', 'spread': '0.3130', 'groupId': 'OG000'}, {'value': '-0.058', 'spread': '0.2909', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).\n\nThe responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. A negative change in the mean indicates a worsening in health status since the beginning of the maintenance phase. A positive change indicates an improvement in health. The minimal important difference in the Health Status Index is 0.074 (range -0.011 to 0.140).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations. No morphine treatment analysis was planned.'}, {'type': 'SECONDARY', 'title': 'Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in the Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '19.80', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '16.94', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '18.55', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from Day 15, a negative mean value indicates a worsening of health-related quality of life since the start of the maintenance phase.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 43 (End of Maintenance Phase)', 'description': 'In the Patient Global Impression of Change (PGIC) the participant is asked "Since I began study treatment, my overall status is". The participant is asked to circle one of seven categories. Scores range from very much improved to very much worse. The question was asked at the end of the maintenance phase with reference to the start of the maintenance phase where the participant continued at the dose that was effective at the end of the Titration Phase.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set, observed.'}, {'type': 'SECONDARY', 'title': 'Quality of Sleep (Sleep Questionnaire) in the Titration Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'title': 'Excellent at the start of the titration phase', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Excellent at the end of the titration phase', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Good at the start of the titration phase', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Good at the end of the titration phase', 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Fair at the start of the titration phase', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Fair at the end of the titration phase', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Poor at the start of the titration phase', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Poor at the end of the titration phase', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Not completed at the start of titration', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Not completed at the end of the titration', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (end of Titration Phase)', 'description': 'Participants were asked the following question: "Please rate the overall quality of your sleep last night?" The quality of sleep from the start of the titration phase to the end of the titration phase was measured. The participant could choose one of the following options: Excellent, good, fair and poor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (Titration Phase), observed. Tapentadol: 302 participants dosed gave a response at the start of titration and from 309 participants at the end of titration.\n\nMorphine: 143 participants dosed gave a response at the start of titration and from 142 participants at the end of titration.'}, {'type': 'SECONDARY', 'title': 'Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'title': 'Excellent at start of maintenance phase', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Excellent at the end of maintenance phase', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Good at start of maintenance phase', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}]}, {'title': 'Good at the end of maintenance phase', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Fair at start of maintenance phase', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Fair at the end of maintenance phase', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}]}, {'title': 'Poor at start of maintenance phase', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Poor at the end of maintenance phase', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'Participants were asked the following question: "Please rate the overall quality of your sleep last night?" The quality of sleep from the start of maintenance to the completion of treatment is reported. The participant could choose one of the following options: Excellent, good, fair and poor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Maintenance Phase) Last Observation Carried Forward for participants re-randomized.\n\nTapentadol: 105 participants responded at the start and 103 participants at the end.\n\nMorphine: 108 participants responded at the start and 107 participants at the end.\n\nPlacebo: 110 participants responded at the start and 107 participants at the end.'}, {'type': 'SECONDARY', 'title': 'Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Moderately Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 (End of Titration Phase)', 'description': 'This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.\n\nThe following withdrawal categories are based on the total COWS score:\n\n* None: total score below 5;\n* Mild: total score from 5 to 12;\n* Moderate: total score 13 to 24;\n* Moderately Severe: total score 25 to 36;\n* Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (Titration Phase). Participants that took at least one dose of trial medication in the titration phase, and discontinued trial medication at the end or during the titration phase and did not continue on other opioid medication.'}, {'type': 'SECONDARY', 'title': 'Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Moderately Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 43 (End of Maintenance Phase)', 'description': 'This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.\n\nThe following withdrawal categories are based on the total COWS score:\n\n* None: total score below 5;\n* Mild: total score from 5 to 12;\n* Moderate: total score 13 to 24;\n* Moderately Severe: total score 25 to 36;\n* Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set. Participants that did not discontinue due to adverse event during the first week of the maintenance phase and started opioid after last study medication.'}, {'type': 'SECONDARY', 'title': 'Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '216', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}], 'classes': [{'title': 'Overall abdominal subscale', 'categories': [{'measurements': [{'value': '-0.062', 'spread': '0.6507', 'groupId': 'OG000'}, {'value': '-0.076', 'spread': '0.7242', 'groupId': 'OG001'}]}]}, {'title': 'Overall rectal subscale', 'categories': [{'measurements': [{'value': '0.059', 'spread': '0.6442', 'groupId': 'OG000'}, {'value': '-0.006', 'spread': '0.6736', 'groupId': 'OG001'}]}]}, {'title': 'Overall stool subscale', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.812', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.870', 'groupId': 'OG001'}]}]}, {'title': 'Overall PAC-SYM score', 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.5782', 'groupId': 'OG000'}, {'value': '0.027', 'spread': '0.6154', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (End of Titration Phase)', 'description': 'The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the titration phase.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set (Titration Phase), observed. Start of Titration and Endpoint Titration observations.'}, {'type': 'SECONDARY', 'title': 'Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '103', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.'}, {'id': 'OG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'classes': [{'title': 'Overall abdominal subscale', 'categories': [{'measurements': [{'value': '-0.105', 'spread': '0.6280', 'groupId': 'OG000'}, {'value': '0.026', 'spread': '0.5966', 'groupId': 'OG001'}, {'value': '-0.075', 'spread': '0.5330', 'groupId': 'OG002'}]}]}, {'title': 'Overall rectal subscale', 'categories': [{'measurements': [{'value': '0.017', 'spread': '0.5086', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.5090', 'groupId': 'OG001'}, {'value': '-0.033', 'spread': '0.5822', 'groupId': 'OG002'}]}]}, {'title': 'Overall stool subscale', 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.743', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.724', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.667', 'groupId': 'OG002'}]}]}, {'title': 'Overall PAC-SYM score', 'categories': [{'measurements': [{'value': '-0.059', 'spread': '0.4992', 'groupId': 'OG000'}, {'value': '0.024', 'spread': '0.4584', 'groupId': 'OG001'}, {'value': '-0.048', 'spread': '0.4771', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the maintenance phase. A negative mean change indicates an improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set (Maintenance Phase), observed. Start of Maintenance and Endpoint Maintenance observations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'FG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'FG002', 'title': 'Matching Placebo After Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo received 100 mg tapentadol prolonged release (PR) twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.'}], 'periods': [{'title': 'Titration Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '338'}, {'groupId': 'FG001', 'numSubjects': '158'}, {'comment': 'All participants in the titration phase were in the tapentadol arm during the titration phase.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Trial Medication non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Discontinuations After Titration Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}, {'groupId': 'FG001', 'numSubjects': '129'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants meeting stabilization criteria on days 13-15 in the titration phase were re-randomized.', 'groupId': 'FG000', 'numSubjects': '218'}, {'comment': 'Participants meeting stabilization criteria on days 13-15 in the titration phase were re-randomized.', 'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Trial Medication non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '106 of 218 participants in the tapentadol titration arm were re-randomized and treated.', 'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'comment': '112 of 218 participants in the tapentadol titration arm were re-randomized and treated.', 'groupId': 'FG002', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '93'}, {'groupId': 'FG002', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Trial medication non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Resolution of pain', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial started on 13 Jun 2007 with the enrollment of the first participant and was completed on 04 Jun 2012 with the last follow-up examination. 622 participants signed informed consent. 505 participants were randomized and 504 had at least one dose of trial medication. 496 participants were part of the safety analysis set.', 'preAssignmentDetails': 'One site was excluded from all analysis sets (efficacy and safety) due to GCP non-compliance. Thus 8 participants who were randomized and treated are not reported in the tables below.\n\nThe participants in the tapentadol titration phase were re-randomized to tapentadol or placebo in the maintenance phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '338', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'BG001', 'title': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '326', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.8', 'spread': '10.39', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '10.21', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '10.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Moldova, Republic of', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Titration Phase:\n\nSafety Analysis Set (N = 496) Full Analysis Set (N = 492)\n\nMaintenance Phase:\n\nSafety Analysis Set (N = 327) Full Analysis Set (N = 325)\n\nNote:\n\nOne site was excluded from all analysis sets (efficacy and safety) due to GCP non-compliance. Thus 8 participants who were randomized and treated are not reported in the tables below.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 622}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2007-05-10', 'resultsFirstSubmitDate': '2013-09-30', 'studyFirstSubmitQcDate': '2007-05-10', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-04-04', 'studyFirstPostDateStruct': {'date': '2007-05-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Scored as Responder in Maintenance Phase.', 'timeFrame': 'Day 18 through Day 43 (End of Maintenance Phase)', 'description': 'A "responder" is a participant in the study that:\n\n1. completed 28 days of the maintenance phase\n2. had a numeric rating scale score below 5 on the 11 point scale (where 0 indicates no pain and 10 indicates worst possible pain. This twice daily current pain score was averaged over Day 18 to Day 43.\n3. did not use more than 20 mg of rescue medication per day on average in the 28 day maintenance period (from Day 18 to Day 43).\n\nA participant that met all 3 of the above-mentioned criteria is counted as a responder, in other words the participant benefited from the assigned drug treatment. A participant that failed to meet only 1 of the 3 criteria is not counted as a responder.'}], 'secondaryOutcomes': [{'measure': 'Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Tapentadol Treatment Arm.', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'Participants were asked to record their "average pain over the last 24 hours" pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".'}, {'measure': 'Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Titration Phase in the Morphine Treatment Arm.', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'Participants were asked to record their "average pain over the last 24 hours" pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".'}, {'measure': 'Average Daily Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.', 'timeFrame': 'Day 18 through Day 43 (End of Maintenance Phase)', 'description': 'Participants were asked to record their "average pain over the last 24 hours" pain intensity each evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".'}, {'measure': 'Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Tapentadol Arm.', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".'}, {'measure': 'Current Pain Intensity Scores, Averaged Per Week, During the Titration Phase in the Morphine Arm.', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".'}, {'measure': 'Current Pain Intensity Scores, Averaged Per Week by Treatment, During the Maintenance Phase.', 'timeFrame': 'Day 15 through Day 43 (End of Maintenance Phase)', 'description': 'Participants were asked to record their current pain intensity in the morning and evening. Average pain scores are the averages of all scores recorded during the 3 days prior to re-randomization or during each week. The participant scored their pain intensity on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".'}, {'measure': 'Use of Rescue Medication in the Titration Phase.', 'timeFrame': 'Day 1 through Day 14 (End of Titration Phase)', 'description': 'The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the titration phase were counted. This data was captured in an electronic diary.\n\nDuring the trial, morphine immediate release 10 mg was allowed as required without a maximum dose defined. However, participants were only re-randomized if their mean consumption of rescue medication was less or equal to 2 doses (20 mg) per day during the last 3 days of the titration phase).'}, {'measure': 'Number of Participants Using Immediate Release Morphine Rescue Medication in the Maintenance Phase', 'timeFrame': 'Day 15 through Day 43 (End of Maintenance Phase)', 'description': "Participants were issued morphine 10 mg immediate release medication. The number of participants using rescue medication morphine sulfate immediate release 10 mg tablets in the maintenance phase were counted. This use of morphine immediate release was captured in each participant's electronic diary."}, {'measure': 'The Average Mean Total Daily Dose of Rescue Medication.', 'timeFrame': 'Day 1 (Start of Titration Phase) through Day 43 (End of Maintenance Phase)', 'description': 'Mean total daily dose of rescue medication morphine sulphate immediate release tablets in milligrams per day (mg/day).'}, {'measure': 'Changes in the Short Form 36® Health Survey (SF-36®) During the Titration Phase.', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (End of Titration Phase)', 'description': 'The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.'}, {'measure': 'Changes in the Short Form 36® Health Survey (SF-36®) During the Maintenance Phase.', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'The Short Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. Low scores on the Physical Component Summary measure indicate limitations in physical functioning, e.g. a high degree of bodily pain and physical limitations etc. For the Mental Component Summary measure, a low score is indicative of frequent psychological distress, social and role disability due to emotional problems etc. The theoretical range for the physical component score is 12.3279 to 59.6503. The theoretical range for the mental component score is 13.5313 to 59.6503. Positive values for changes in the component scores indicate an improvement.'}, {'measure': 'Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Change From Start of Titration to Endpoint Titration.', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (End of Titration Phase)', 'description': 'The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).\n\nThe responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. A positive change in the mean indicates that during this phase the health status improved. A positive change indicates an improvement in health. The minimal important difference is 0.074 (range -0.011 to 0.140).'}, {'measure': 'Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Titration Phase.', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (End of Titration Phase)', 'description': 'EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate better health. The values indicated represent the change from Day 1, a positive value indicates an improvement since the start of treatment.'}, {'measure': 'Change in the EuroQoL (EQ-5D) Health Status Index (United Kingdom Time Trade-off Value Set) Over Time in the Maintenance Phase for Tapentadol and the Placebo Randomized Withdrawal Treatment Arms.', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'The participant scores the EuroQol-5D. The EuroQoL-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1 = no problems, 2 = some problems, 3 = extreme problems).\n\nThe responses to the five EQ-5D dimensions are scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing dead. A negative change in the mean indicates a worsening in health status since the beginning of the maintenance phase. A positive change indicates an improvement in health. The minimal important difference in the Health Status Index is 0.074 (range -0.011 to 0.140).'}, {'measure': 'Changes in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) Maintenance Phase.', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from Day 15, a negative mean value indicates a worsening of health-related quality of life since the start of the maintenance phase.'}, {'measure': 'Patient Global Impression of Change', 'timeFrame': 'Day 43 (End of Maintenance Phase)', 'description': 'In the Patient Global Impression of Change (PGIC) the participant is asked "Since I began study treatment, my overall status is". The participant is asked to circle one of seven categories. Scores range from very much improved to very much worse. The question was asked at the end of the maintenance phase with reference to the start of the maintenance phase where the participant continued at the dose that was effective at the end of the Titration Phase.'}, {'measure': 'Quality of Sleep (Sleep Questionnaire) in the Titration Phase.', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (end of Titration Phase)', 'description': 'Participants were asked the following question: "Please rate the overall quality of your sleep last night?" The quality of sleep from the start of the titration phase to the end of the titration phase was measured. The participant could choose one of the following options: Excellent, good, fair and poor.'}, {'measure': 'Quality of Sleep (Sleep Questionnaire) During the Maintenance Phase of the Trial.', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'Participants were asked the following question: "Please rate the overall quality of your sleep last night?" The quality of sleep from the start of maintenance to the completion of treatment is reported. The participant could choose one of the following options: Excellent, good, fair and poor.'}, {'measure': 'Clinical Opioid Withdrawal Scale (COWS) at the End of the Titration Phase.', 'timeFrame': 'Day 14 (End of Titration Phase)', 'description': 'This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.\n\nThe following withdrawal categories are based on the total COWS score:\n\n* None: total score below 5;\n* Mild: total score from 5 to 12;\n* Moderate: total score 13 to 24;\n* Moderately Severe: total score 25 to 36;\n* Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication.'}, {'measure': 'Clinical Opioid Withdrawal Score (COWS) at the End of the Maintenance Phase.', 'timeFrame': 'Day 43 (End of Maintenance Phase)', 'description': 'This instrument was developed by the National Institute on Drug Abuse. The physical components of withdrawal are primarily evaluated and based on questions and clinical observations. The possible opioid withdrawal effects are assessed using the Clinical Opioid Withdrawal Score (COWS). The COWS is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. Responses are rated on a Likert-type scale ranging from 0 to 4 or 5 depending on the item. The total COWS score is the sum of all individual items.\n\nThe following withdrawal categories are based on the total COWS score:\n\n* None: total score below 5;\n* Mild: total score from 5 to 12;\n* Moderate: total score 13 to 24;\n* Moderately Severe: total score 25 to 36;\n* Severe: total score above 36. The investigator completes the COWS after participants discontinued trial medication 2 to less than 5 days after last intake of trial medication.'}, {'measure': 'Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Titration Phase', 'timeFrame': 'Day 1 (Start of Titration); Day 14 (End of Titration Phase)', 'description': 'The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the titration phase.'}, {'measure': 'Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) During the Maintenance Phase', 'timeFrame': 'Day 15 (Start of Maintenance); Day 43 (End of Maintenance Phase)', 'description': 'The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assesses the severity of symptoms of constipation. Participants are asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on Abdominal symptoms, 3 questions on rectal symptoms and 5 questions on stool symptoms. Responses are rated on a 5-point Likert Scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). The changes in overall mean and in each of the mean sub-scores vary theoretically from -4 to +4 (where a change of +4 would indicate a change from not present to very severe symptom). If the changes in the overall or subscale mean scores are positive then there is a worsening in symptoms associated with constipation from the start to the end of the maintenance phase. A negative mean change indicates an improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid', 'Central acting analgesic', 'CG5503 PR', 'Tumor related pain', 'Cancer related pain', 'Morphine', 'Pain assessment', 'Placebo'], 'conditions': ['Tumor', 'Pain']}, 'referencesModule': {'references': [{'pmid': '25054392', 'type': 'RESULT', 'citation': 'Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Lange B, Dogan C, Etropolski MS, Eerdekens M. Tapentadol prolonged release for managing moderate to severe, chronic malignant tumor-related pain. Pain Physician. 2014 Jul-Aug;17(4):329-43.'}, {'pmid': '27062079', 'type': 'RESULT', 'citation': 'Kress HG, Koch ED, Kosturski H, Steup A, Karcher K, Dogan C, Etropolski M, Eerdekens M. Direct conversion from tramadol to tapentadol prolonged release for moderate to severe, chronic malignant tumour-related pain. Eur J Pain. 2016 Oct;20(9):1513-8. doi: 10.1002/ejp.875. Epub 2016 Apr 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to determine whether tapentadol (CG5503) is effective and safe in the treatment of chronic tumor related pain compared to placebo. In addition tapentadol (CG5503) will also be compared to morphine controlled release, also referred to as slow release (SR).\n\n\\*Tapentadol prolonged-release (PR) is the term used in the European Union and is referred to as extended release (ER) in the United States.', 'detailedDescription': 'Normally chronic tumor related pain is controlled when participants receive repeated doses of opioid analgesics. However, opioid therapy is commonly associated with side effects such as nausea, vomiting, sedation, constipation, addiction, tolerance, and respiratory depression. Tapentadol (CG5503), a newly synthesized drug with an prolonged release (PR) formulation, also acts as a centrally acting pain reliever but has 2 mechanisms of action. The aim of this trial is to investigate the effectiveness (level of pain control) and safety (side effects) of tapentadol (CG5503) PR compared with no drug (placebo) and corresponding dose of morphine (an opioid commonly used to treat tumor related pain). This trial is a randomized, double-blind (neither investigator nor patient will know which treatment was received), active- and placebo-controlled, parallel-group, randomized withdrawal design, multicenter trial.\n\nThe trial includes a 2 week titration phase starting with either 40 mg morphine (PR) bid (bid = twice daily dosing, one dose in the morning and one dose in the evening) or 100 mg tapentadol (CG5503) PR bid. Based on effectiveness and side effects subjects can up-titrate in steps of 50 mg tapentadol (CG5503 PR) to a maximal dose of 250 mg tapentadol (CG5503) PR bid or 100 mg morphine PR bid. If participants meet the stabilisation criteria at the end of the titration phase they will be re-randomized to either placebo or active treatment and will continue 4 weeks at the last dose level in the maintenance phase. Only participants on tapentadol in the titration phase will be re-randomized to either matching placebo or to tapentadol. To maintain the blinding nature of the trial participants in the morphine arm during the titration phase will also be re-randomized however they will all remain on morphine controlled release in the maintenance phase. Placebo to match tapentadol tablets, as well as placebo to match morphine capsules, will be used to mask the treatment allocation.\n\nParticipants will be issued with an electronic diary (eDiary) to capture Numeric Rating Scale (NRS) pain intensities.\n\nAssessments of pain relief include the pain intensity numeric rating scale (NRS) and patient global impression of change (PGIC). Safety evaluations include monitoring of adverse events, physical examinations, clinical laboratory tests and electrocardiograms. Venous blood samples will be collected for the determination of serum concentrations of tapentadol (CG5503).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male and non-pregnant, non-lactating female subjects.\n* Of at least 18 years of age with chronic malignant tumor-related pain with a mean pain intensity (NRS) of 5 points or higher.\n* Subjects who are opioid-naïve or pretreated with an equianalgesic dose range equivalent of up to 160 mg oral morphine per day and are dissatisfied with prior treatment.\n* Women must be postmenopausal, surgically sterile, or practicing or agree to practice an effective method of birth control throughout the trial.\n* Expected course of the disease and the pain that would permit compliance with the trial protocol over the entire trial period.\n\nExclusion Criteria\n\nKey Exclusion Criteria:\n\n* Subjects will be excluded from the study if they have a history of seizure disorder or epilepsy;\n* known history and/or presence of cerebral tumor or cerebral metastases.\n* history of alcohol or drug abuse;\n* uncontrolled hypertension,\n* clinical laboratory values reflecting severe renal insufficiency,\n* moderate or severe hepatic impairment,\n* hepatitis B or C, HIV,\n* inadequate bone marrow reserve\n* currently treated with radiotherapy,\n* pain-inducing chemotherapy,\n* anti-parkinsonian drugs, neuroleptics, monoamine oxidase inhibitors, serotonin norepinephrine reuptake inhibitor (SNRI) or any other analgesic therapy than investigational medication or rescue medication during the trial.\n* selective serotonin reuptake inhibitor (SSRI) treatments are allowed if taken for at least 30 days before the screening period of the study at an unchanged dose.'}, 'identificationModule': {'nctId': 'NCT00472303', 'briefTitle': 'A Study to Evaluate Tapentadol (CG5503) in the Treatment of Chronic Tumor-Related Pain Compared With Placebo and Morphine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grünenthal GmbH'}, 'officialTitle': 'A Randomized Withdrawal, Active- and Placebo-controlled, Double-blind, Multi-center Phase III Trial Assessing Safety and Efficacy of Oral CG5503 (Tapentadol) PR* in Subjects With Moderate to Severe Chronic Malignant Tumor-related Pain', 'orgStudyIdInfo': {'id': '761101'}, 'secondaryIdInfos': [{'id': '2006-004997-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'KF5503/15', 'type': 'OTHER', 'domain': 'Grünenthal'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Matching Placebo after Tapentadol in Titration Phase', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.', 'interventionNames': ['Drug: Tapentadol Extended Release', 'Drug: Matching Placebo after Tapentadol in the Titration Phase.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine Controlled Release', 'description': 'Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. Maintenance phase: continuing on dose level established in titration phase.', 'interventionNames': ['Drug: Morphine Sulphate Controlled Release']}, {'type': 'EXPERIMENTAL', 'label': 'Tapentadol Prolonged Release', 'description': 'Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses.', 'interventionNames': ['Drug: Tapentadol Extended Release']}], 'interventions': [{'name': 'Tapentadol Extended Release', 'type': 'DRUG', 'otherNames': ['Palexia', 'Nucynta', 'Yantil'], 'description': 'Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: Starting at 100 mg, increasing at a minimum of 3 day intervals by 50 mg, with a maximum dose of 250 mg.', 'armGroupLabels': ['Matching Placebo after Tapentadol in Titration Phase', 'Tapentadol Prolonged Release']}, {'name': 'Matching Placebo after Tapentadol in the Titration Phase.', 'type': 'DRUG', 'description': 'Tablet taken orally, twice daily, morning \\& evening with preferably 12 hours (not less than 6 hours) between doses. 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