Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-27 @ 10:08 PM
Study NCT ID:
NCT00261495
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2005-12-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kpappert@its.jnj.com', 'phone': '+49 4107 312356', 'title': 'EMEA Medical Affairs Director Analgesia', 'organization': 'Janssen Pharmaceutica NV'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)', 'otherNumAtRisk': 254, 'otherNumAffected': 206, 'seriousNumAtRisk': 254, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)', 'otherNumAtRisk': 250, 'otherNumAffected': 212, 'seriousNumAtRisk': 250, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 92, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 76, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 45, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 82, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 92, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 43, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 37, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 33, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 30, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 32, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 23, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 35, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colonic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mechanical ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Postoperative fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biopsy liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spondyloarthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Prosthesis implantation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rehabilitation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Umbilical hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 250, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Per Protocol [PP] Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '-0.27', 'ciUpperLimit': '0.84', 'pValueComment': 'Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \\& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).', 'estimateComment': 'LS mean difference has been presented, which was calculated as hydromorphone minus oxycodone.', 'groupDescription': 'Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.\n\nAlternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.\n\nSample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'If the right side of CI\\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Tested using 95% confidence interval approach. The non-inferiority margin was 1.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (all randomized subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity Sub-score "Pain at Its Worst" (BPI Item 3) at Week 24 (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.706', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.47', 'pValueComment': 'A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure was stopped here, subsequent tests were exploratory in nature.', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.\n\nAlternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in BPI Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Intent to Treat [ITT] Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.53', 'ciUpperLimit': '0.29', 'pValueComment': 'Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means \\& error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.\n\nAlternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.\n\nSample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'If the right side of CI\\<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Tested using 95% confidence interval approach. The non-inferiority margin was 1.'}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.8', 'spread': '18.44', 'groupId': 'OG000'}, {'value': '-6.2', 'spread': '18.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.065', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.87', 'ciLowerLimit': '-5.94', 'ciUpperLimit': '0.19', 'pValueComment': 'A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.\n\nAlternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Diary Evening Mean Pain Score "Pain Right Now" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.62', 'ciUpperLimit': '0.22', 'pValueComment': 'A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.', 'estimateComment': 'Mean difference was calculated: hydromorphone minus oxycodone', 'groupDescription': 'Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.\n\nAlternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline to week 24 in subject diary evening mean pain score "pain right now". Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score "pain right now".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Diary Morning Mean Pain Score "Pain Right Now" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.616', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '0.32', 'pValueComment': 'A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.', 'estimateComment': 'Mean difference was calculated: hydromorphone minus oxycodone', 'groupDescription': 'Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.\n\nAlternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline to week 24 in subject diary morning mean pain score "pain right now". Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score "pain right now".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Dose Escalation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.249', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Hierarchical testing procedure has been stopped, test is exploratory in nature.', 'groupDescription': 'Null hypothesis: There is no association between study medication and dose escalation.\n\nAlternative hypothesis: There is an association between study medication and dose escalation.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran-Mantel-Haenszel Chi-squared statistic stratified for country was used.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'week 4 and week 24', 'description': 'Number of subjects with dose increase in study medication.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Severity Score "Pain Right Now" (BPI Item 6) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.050', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '-0.00', 'ciUpperLimit': '0.84', 'pValueComment': '0.05 two-sided testing, exploratory comparison', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain right now" (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity Score "Pain at Its Least" (BPI Item 4) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.67', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its least" (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its least".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity "Pain at Its Worst" (BPI Item 3) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '1.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.79', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its worst" (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.210', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.59', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hdromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "average pain" (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "average pain".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'spread': '25.15', 'groupId': 'OG000'}, {'value': '15.2', 'spread': '26.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.941', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.18', 'ciLowerLimit': '-4.87', 'ciUpperLimit': '4.52', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.76', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.65', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity "Pain at Its Least" (BPI Item 4) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.431', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.22', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its least" (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its least".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.835', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.33', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "average pain" (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "average pain".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '29.32', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '28.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.837', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-5.36', 'ciUpperLimit': '4.35', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '2.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.832', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '0.31', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Interference Score "Interfered With General Activity" (BPI Item 9a) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.71', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a "pain interfered with general activity" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with general activity".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.345', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-0.23', 'ciUpperLimit': '0.64', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b "pain interfered with mood" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with mood".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '2.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.552', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.14', 'ciLowerLimit': '-0.33', 'ciUpperLimit': '0.61', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c "pain interfered with walking ability" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with walking ability".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.93', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d "pain interfered with normal work" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with normal work".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.81', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e "pain interfered with relations with other people" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with relations with other people".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '3.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.475', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.17', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.65', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f "pain interfered with sleep" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with sleep".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.62', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '2.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.359', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.23', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.72', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g "pain interfered with enjoyment of life" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in "pain interfered with enjoyment of life".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With General Activity" (BPI Item 9a) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '2.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.611', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.30', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a "pain interfered with general activity" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with general activity".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.85', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.60', 'ciUpperLimit': '0.31', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b "pain interfered with mood" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with mood".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.769', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.06', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '0.36', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c "pain interfered with walking ability" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with walking ability".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.843', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.49', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d "pain interfered with normal work" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with normal work".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.92', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '2.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.977', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.44', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e "pain interfered with relations with other people" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with relations with other people".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '2.76', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '3.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.977', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.49', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f "pain interfered with sleep" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with sleep".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.91', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '3.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.902', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.51', 'ciUpperLimit': '0.45', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g "pain interfered with enjoyment of life" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with enjoyment of life".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Pain severity, BPI items 3 to 6', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.13', 'groupId': 'OG001'}]}]}, {'title': 'Pain relief, BPI item 8', 'categories': [{'measurements': [{'value': '17.7', 'spread': '26.36', 'groupId': 'OG000'}, {'value': '23.6', 'spread': '25.46', 'groupId': 'OG001'}]}]}, {'title': 'Pain right now, BPI item 6', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '2.16', 'groupId': 'OG001'}]}]}, {'title': 'Pain at its worst, BPI item 3', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Pain at its least, BPI item 4', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '2.59', 'groupId': 'OG001'}]}]}, {'title': 'Average pain, BPI item 5', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '1.78', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.21', 'groupId': 'OG001'}]}]}, {'title': 'Pain interfered general activity, BPI item 9a', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.40', 'groupId': 'OG001'}]}]}, {'title': 'Pain interfered mood, BPI item 9b', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Pain interfered walking ability, BPI item 9c', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '2.89', 'groupId': 'OG001'}]}]}, {'title': 'Pain interfered normal work, BPI item 9d', 'categories': [{'measurements': [{'value': '-2.9', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '2.63', 'groupId': 'OG001'}]}]}, {'title': 'Pain interfered relation other people, BPI item 9e', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': 'BPI pain interfered sleep, BPI item 9f', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': 'BPI pain interfered enjoyment of life, BPI item 9g', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '3.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 52', 'description': 'Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality (MOS Index I) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.6', 'spread': '17.61', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '18.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.36', 'ciLowerLimit': '-5.74', 'ciUpperLimit': '1.02', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality (MOS Index II) at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.5', 'spread': '16.40', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '17.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.245', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.89', 'ciLowerLimit': '-5.09', 'ciUpperLimit': '1.31', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality (MOS Index II) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.9', 'spread': '17.28', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '16.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.64', 'ciLowerLimit': '-5.51', 'ciUpperLimit': '0.23', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.1', 'spread': '22.77', 'groupId': 'OG000'}, {'value': '-11.7', 'spread': '22.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.297', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.03', 'ciLowerLimit': '-5.85', 'ciUpperLimit': '1.80', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality, Snoring at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '22.04', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '21.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.205', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '2.41', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '6.14', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'spread': '28.44', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '24.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-3.35', 'ciLowerLimit': '-7.43', 'ciUpperLimit': '0.73', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'spread': '28.10', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '26.63', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.475', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.60', 'ciLowerLimit': '-2.80', 'ciUpperLimit': '6.00', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '21.70', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '20.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-4.16', 'ciLowerLimit': '-7.67', 'ciUpperLimit': '-0.65', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality, Sleep Quantity at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.880', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.26', 'pValueComment': '0.05 two-sided test', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Indicating That They Had Optimal Sleep at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.320', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and week 24', 'description': 'Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'MOS sleep disturbance', 'categories': [{'measurements': [{'value': '-17.6', 'spread': '22.44', 'groupId': 'OG000'}, {'value': '-20.1', 'spread': '23.17', 'groupId': 'OG001'}]}]}, {'title': 'MOS snoring', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '23.01', 'groupId': 'OG000'}, {'value': '-4.7', 'spread': '23.86', 'groupId': 'OG001'}]}]}, {'title': 'MOS sleep shortness of breath or headache', 'categories': [{'measurements': [{'value': '-8.4', 'spread': '19.89', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '21.94', 'groupId': 'OG001'}]}]}, {'title': 'MOS sleep adequacy', 'categories': [{'measurements': [{'value': '12.3', 'spread': '27.06', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '30.74', 'groupId': 'OG001'}]}]}, {'title': 'MOS sleep somnolence', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '20.49', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '21.54', 'groupId': 'OG001'}]}]}, {'title': 'MOS sleep quantity', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 52', 'description': 'Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Indicating Optimal Sleep at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'week 52', 'description': 'Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Evening worst pain', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.31', 'groupId': 'OG001'}]}]}, {'title': 'Evening least pain', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '2.28', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '2.36', 'groupId': 'OG001'}]}]}, {'title': 'Evening average pain', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': 'Morning worst pain', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.34', 'groupId': 'OG001'}]}]}, {'title': 'Morning least pain', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '2.44', 'groupId': 'OG001'}]}]}, {'title': 'Morning average pain', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.30', 'groupId': 'OG001'}]}]}, {'title': 'All day worst pain', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-2.1', 'spread': '2.09', 'groupId': 'OG001'}]}]}, {'title': 'All day least pain', 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': 'All day average pain', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'All day pain right now', 'categories': [{'measurements': [{'value': '-2.1', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '2.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.88', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.28', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and weeks 4, 8, 12, 16, 20, and 24', 'description': 'Change from baseline in subject diary mean pain score "pain at its worst" from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score "pain at its worst".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Dose Escalation at Week 4 (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.575', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'week 4', 'description': 'The number of subjects with dose increase in study medication was assessed at week 4.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Dose Escalation at Week 24 (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.807', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'week 24', 'description': 'The number of subjects with dose increase in study medication was assessed at week 24.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life (QoL) "Bodily Pain" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.7', 'spread': '18.10', 'groupId': 'OG000'}, {'value': '16.7', 'spread': '18.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.61', 'ciLowerLimit': '-5.88', 'ciUpperLimit': '0.67', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "General Health Perceptions" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '14.43', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '16.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.956', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-3.08', 'ciUpperLimit': '2.91', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Health Transition" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.08', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.299', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.26', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Mental Health" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '15.76', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '17.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.471', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.13', 'ciLowerLimit': '-4.20', 'ciUpperLimit': '1.95', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxymorphone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Physical Functioning" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.7', 'spread': '17.05', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '16.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '3.84', 'ciLowerLimit': '0.48', 'ciUpperLimit': '7.19', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Role Emotional" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '43.25', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '48.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.556', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '2.40', 'ciLowerLimit': '-5.61', 'ciUpperLimit': '10.42', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 "role emotional" score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in "role emotional".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Role Physical" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'spread': '36.84', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '36.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.551', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.12', 'ciLowerLimit': '-9.11', 'ciUpperLimit': '4.88', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Social Functioning" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '25.33', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '26.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.207', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.98', 'ciLowerLimit': '-7.63', 'ciUpperLimit': '1.66', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Vitality" at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '16.92', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '17.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.123', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-2.46', 'ciLowerLimit': '-5.60', 'ciUpperLimit': '0.68', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Bodily Pain" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '21.04', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '19.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.602', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.90', 'ciLowerLimit': '-4.27', 'ciUpperLimit': '2.48', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "General Health Perceptions" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '17.04', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '16.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.647', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '-2.14', 'ciUpperLimit': '3.44', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Health Transition" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.10', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Mental Health" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '19.30', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '18.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.414', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-1.30', 'ciLowerLimit': '-4.45', 'ciUpperLimit': '1.84', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Physical Functioning" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '19.09', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '15.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '4.05', 'ciLowerLimit': '0.94', 'ciUpperLimit': '7.16', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Role Emotional" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'spread': '47.71', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '47.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.955', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-7.20', 'ciUpperLimit': '7.62', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 "role emotional" score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in "role emotional."', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Role Physical" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'spread': '37.80', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '34.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.669', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.31', 'ciLowerLimit': '-4.72', 'ciUpperLimit': '7.34', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Social Functioning" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '27.81', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '26.85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.595', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '-3.15', 'ciUpperLimit': '5.49', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL "Vitality" at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '19.73', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '17.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.543', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '-0.94', 'ciLowerLimit': '-3.98', 'ciUpperLimit': '2.10', 'estimateComment': 'Mean difference calculated: hydromorphone minus oxycodone', 'groupDescription': 'Exploratory comparison', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in QoL at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'SF-36 bodily pain index', 'categories': [{'measurements': [{'value': '23.1', 'spread': '22.07', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '22.67', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 general health perceptions', 'categories': [{'measurements': [{'value': '9.6', 'spread': '17.86', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '18.97', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 health transition', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 mental health', 'categories': [{'measurements': [{'value': '11.7', 'spread': '17.21', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '26.03', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 physical functioning', 'categories': [{'measurements': [{'value': '11.4', 'spread': '20.10', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '20.12', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 role emotional', 'categories': [{'measurements': [{'value': '22.1', 'spread': '48.86', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '56.86', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 role physical', 'categories': [{'measurements': [{'value': '17.0', 'spread': '38.02', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '33.50', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 social functioning', 'categories': [{'measurements': [{'value': '15.4', 'spread': '23.11', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '28.29', 'groupId': 'OG001'}]}]}, {'title': 'SF-36 vitality', 'categories': [{'measurements': [{'value': '11.5', 'spread': '17.39', 'groupId': 'OG000'}, {'value': '11.9', 'spread': '21.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and week 52', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Clinical Global Assessment of Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Visit 5, week 4: very good', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5, week 4: good', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5, week 4: moderate', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5, week 4: poor', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5, week 4: very poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 8, week 24: very good', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}, {'title': 'Visit 8, week 24: good', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}]}, {'title': 'Visit 8, week 24: moderate', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Visit 8, week 24: poor', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'Visit 8, week 24: very poor', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10, week 52: very good', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10, week 52: good', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10, week 52: moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10, week 52: poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 10, week 52: very poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 4, 24, and 52', 'description': 'Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change in Dose of Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': '0 mg (week 4)', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': '+8 mg (week 4)', 'categories': [{'measurements': [{'value': '102', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '+20 mg (week 4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': '+24 mg (week 4)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '+60 mg (week 4)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}, {'title': '-60 mg (week 24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '-40 mg (week 24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '-24 mg (week 24)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-20 mg (week 24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '-16 mg (week 24)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-8 mg (week 24)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '0 mg (week 24)', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': '+8 mg (week 24)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '+16 mg (week 24)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '+20 mg (week 24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': '+40 mg (week 24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': '-16 mg (week 52)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '-8 mg (week 52)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '0 mg (week 52)', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': '+40 mg (week 52)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 4, 24, and 52', 'description': 'Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Titration phase (on study at least 4 weeks) 0 mg', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study at least 4 weeks) +8 mg', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study at least 4 weeks) +20 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study at least 4 weeks) +24 mg', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study at least 4 weeks) +60 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study <4 weeks) 0 mg', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study <4 weeks) +8 mg', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study <4 weeks) +20 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study <4 weeks) +24 mg', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Titration phase (on study <4 weeks) +60 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study at least 4 weeks) 0 mg', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study at least 4 weeks ) +4 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study at least 4 weeks ) +8 mg', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study at least 4 weeks) +20 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study at least 4 weeks ) +24 mg', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study at least 4 weeks) +60 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study <4 weeks) 0 mg', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study <4 weeks) +8 mg', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study <4 weeks) +20 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study <4 weeks) +24 mg', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (on study <4 weeks) +60 mg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 4 and 24', 'description': 'Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Number of Drop-outs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Adverse events (core)', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Adverse events (extension)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Consent withdrawn (core)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Consent withdrawn (extension)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Inadequate pain relief (core)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Inadequate pain relief (extension)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Investigator withdrew patient (core)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Investigator withdrew patient (extension)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lost to follow up (core)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lost to follow up (extension)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Non compliance (core)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Non compliance (extension)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other (core)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Other (extension)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Protocol violation (core)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Protocol violation (extension)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment completed no follow up visit (core)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment completed no follow up visit (extension)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Inefficacy at maximal dosage (core)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'baseline to week 24 (core); week 24 to week 52 (extension)', 'description': 'Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Number of Days With add-on Pain Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '68.2', 'spread': '59.6', 'groupId': 'OG000'}, {'value': '66.1', 'spread': '61.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 24', 'description': 'Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Amount of add-on Pain Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '80004.8', 'spread': '97004.53', 'groupId': 'OG000'}, {'value': '76191.9', 'spread': '96925.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Mode and Convenience of Drug Intake.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'title': 'Very convenient, week 4', 'categories': [{'measurements': [{'value': '57', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '36', 'spread': '0.77', 'groupId': 'OG001'}]}]}, {'title': 'Convenient, week 4', 'categories': [{'measurements': [{'value': '97', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '94', 'spread': '1.01', 'groupId': 'OG001'}]}]}, {'title': 'Neither convenient or inconvenient, week 4', 'categories': [{'measurements': [{'value': '30', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '30', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Inconvenient, week 4', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Very inconvenient, week 4', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Very convenient, week 24', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}, {'title': 'Convenient, week 24', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}, {'title': 'Neither convenient or inconvenient, week 24', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Inconvenient, week 24', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Very inconvenient, week 24', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Very convenient, week 52', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Convenient, week 52', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Neither convenient or inconvenient, week 52', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Inconvenient, week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Very inconvenient, week 52', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'weeks 4, 24, and 52', 'description': 'Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'SECONDARY', 'title': 'Resource Utilization of Pain Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 24', 'description': 'Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24.', 'unitOfMeasure': 'Additional visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'PRIMARY', 'title': 'Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'spread': '9.44', 'groupId': 'OG000'}, {'value': '48.3', 'spread': '22.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 24', 'description': 'If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.', 'unitOfMeasure': 'mg per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)'}, {'type': 'PRIMARY', 'title': 'Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'spread': '9.92', 'groupId': 'OG000'}, {'value': '43.8', 'spread': '23.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 24', 'description': 'If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.', 'unitOfMeasure': 'mg per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}, {'type': 'PRIMARY', 'title': 'Equi-analgesic Dose at Steady-state (PP Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '18.95', 'spread': '9.223', 'groupId': 'OG000'}, {'value': '47.82', 'spread': '21.663', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4 to week 24', 'description': 'Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.', 'unitOfMeasure': 'mg per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)'}, {'type': 'PRIMARY', 'title': 'Equi-analgesic Dose at Steady State (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '250', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'OG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'classes': [{'categories': [{'measurements': [{'value': '19.50', 'spread': '9.584', 'groupId': 'OG000'}, {'value': '48.41', 'spread': '21.835', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 4 to week 24', 'description': 'Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.', 'unitOfMeasure': 'mg per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'FG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}], 'periods': [{'title': 'Titration Phase (Weeks 0 to 4)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '250'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}, {'title': 'Maintenance Phase (Weeks 4 to 24)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '185'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Treatment completed, no follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Extension Phase (Weeks 24 to 52)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Number started is different to number completed maintenance phase owing to drop outs (80 subjects).', 'groupId': 'FG000', 'numSubjects': '60'}, {'comment': 'Number started is different to number completed maintenance phase owing to drop outs (85 subjects).', 'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study conducted in 11 countries (Czech Republic, Denmark, France, Germany, Italy, Norway, Poland, Slovakia, Slovenia, Sweden, and Switzerland). 63 study centres randomized subjects and 1 centre screened 1 subject but did not randomize. Recruitment period: 15 March 2006 (first patient in) to 31 March 2007 (last patient in).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '250', 'groupId': 'BG001'}, {'value': '504', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OROS Hydromorphone HCl', 'description': 'Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)'}, {'id': 'BG001', 'title': 'Oxycodone', 'description': 'Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '13.06', 'groupId': 'BG000'}, {'value': '58.0', 'spread': '12.82', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '12.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Slovenia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-21', 'studyFirstSubmitDate': '2005-12-02', 'resultsFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2005-12-02', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-20', 'studyFirstPostDateStruct': {'date': '2005-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Per Protocol [PP] Population)', 'timeFrame': 'baseline and week 24', 'description': 'Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".'}, {'measure': 'Change From Baseline in BPI Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Intent to Treat [ITT] Population)', 'timeFrame': 'baseline and week 24', 'description': 'Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".'}, {'measure': 'Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)', 'timeFrame': 'week 24', 'description': 'If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.'}, {'measure': 'Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)', 'timeFrame': 'week 24', 'description': 'If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose\\*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.'}, {'measure': 'Equi-analgesic Dose at Steady-state (PP Population)', 'timeFrame': 'week 4 to week 24', 'description': 'Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.'}, {'measure': 'Equi-analgesic Dose at Steady State (ITT Population)', 'timeFrame': 'week 4 to week 24', 'description': 'Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in BPI Pain Severity Sub-score "Pain at Its Worst" (BPI Item 3) at Week 24 (ITT Population)', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".'}, {'measure': 'Change From Baseline in Sleep Quality at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality.'}, {'measure': 'Change From Baseline in Subject Diary Evening Mean Pain Score "Pain Right Now" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline to week 24 in subject diary evening mean pain score "pain right now". Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score "pain right now".'}, {'measure': 'Change From Baseline in Subject Diary Morning Mean Pain Score "Pain Right Now" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline to week 24 in subject diary morning mean pain score "pain right now". Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score "pain right now".'}, {'measure': 'Number of Subjects With Dose Escalation', 'timeFrame': 'week 4 and week 24', 'description': 'Number of subjects with dose increase in study medication.'}, {'measure': 'Change From Baseline in BPI Severity Score "Pain Right Now" (BPI Item 6) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain right now" (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".'}, {'measure': 'Change From Baseline in BPI Pain Severity Score "Pain at Its Least" (BPI Item 4) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its least" (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its least".'}, {'measure': 'Change From Baseline in BPI Pain Severity "Pain at Its Worst" (BPI Item 3) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its worst" (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".'}, {'measure': 'Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "average pain" (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "average pain".'}, {'measure': 'Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.'}, {'measure': 'Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity.'}, {'measure': 'Change From Baseline in BPI Pain Severity "Pain at Its Least" (BPI Item 4) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its least" (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its least".'}, {'measure': 'Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "average pain" (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "average pain".'}, {'measure': 'Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.'}, {'measure': 'Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity.'}, {'measure': 'Change From Baseline in BPI Interference Score "Interfered With General Activity" (BPI Item 9a) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a "pain interfered with general activity" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with general activity".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b "pain interfered with mood" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with mood".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c "pain interfered with walking ability" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with walking ability".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d "pain interfered with normal work" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with normal work".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e "pain interfered with relations with other people" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with relations with other people".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f "pain interfered with sleep" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with sleep".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g "pain interfered with enjoyment of life" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in "pain interfered with enjoyment of life".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With General Activity" (BPI Item 9a) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a "pain interfered with general activity" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with general activity".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b "pain interfered with mood" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with mood".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c "pain interfered with walking ability" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with walking ability".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d "pain interfered with normal work" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with normal work".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e "pain interfered with relations with other people" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with relations with other people".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f "pain interfered with sleep" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with sleep".'}, {'measure': 'Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g "pain interfered with enjoyment of life" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with enjoyment of life".'}, {'measure': 'Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)', 'timeFrame': 'baseline and week 52', 'description': 'Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.'}, {'measure': 'Change From Baseline in Sleep Quality (MOS Index I) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.'}, {'measure': 'Change From Baseline in Sleep Quality (MOS Index II) at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.'}, {'measure': 'Change From Baseline in Sleep Quality (MOS Index II) at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.'}, {'measure': 'Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance.'}, {'measure': 'Change From Baseline in Sleep Quality, Snoring at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring.'}, {'measure': 'Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache.'}, {'measure': 'Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy.'}, {'measure': 'Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence.'}, {'measure': 'Change From Baseline in Sleep Quality, Sleep Quantity at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity.'}, {'measure': 'Number of Subjects Indicating That They Had Optimal Sleep at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night.'}, {'measure': 'Change From Baseline in Sleep Quality at Week 52', 'timeFrame': 'baseline and week 52', 'description': 'Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures.'}, {'measure': 'Number of Subjects Indicating Optimal Sleep at Week 52', 'timeFrame': 'week 52', 'description': 'Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night.'}, {'measure': 'Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores.'}, {'measure': 'Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24', 'timeFrame': 'baseline and weeks 4, 8, 12, 16, 20, and 24', 'description': 'Change from baseline in subject diary mean pain score "pain at its worst" from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score "pain at its worst".'}, {'measure': 'Number of Subjects With Dose Escalation at Week 4 (ITT Population)', 'timeFrame': 'week 4', 'description': 'The number of subjects with dose increase in study medication was assessed at week 4.'}, {'measure': 'Number of Subjects With Dose Escalation at Week 24 (ITT Population)', 'timeFrame': 'week 24', 'description': 'The number of subjects with dose increase in study medication was assessed at week 24.'}, {'measure': 'Change From Baseline in Quality of Life (QoL) "Bodily Pain" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.'}, {'measure': 'Change From Baseline in QoL "General Health Perceptions" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions.'}, {'measure': 'Change From Baseline in QoL "Health Transition" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.'}, {'measure': 'Change From Baseline in QoL "Mental Health" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score.'}, {'measure': 'Change From Baseline in QoL "Physical Functioning" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.'}, {'measure': 'Change From Baseline in QoL "Role Emotional" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 "role emotional" score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in "role emotional".'}, {'measure': 'Change From Baseline in QoL "Role Physical" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.'}, {'measure': 'Change From Baseline in QoL "Social Functioning" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.'}, {'measure': 'Change From Baseline in QoL "Vitality" at Week 4', 'timeFrame': 'baseline and week 4', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.'}, {'measure': 'Change From Baseline in QoL "Bodily Pain" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 bodily pain index score at week 24. Score could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.'}, {'measure': 'Change From Baseline in QoL "General Health Perceptions" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in health perceptions.'}, {'measure': 'Change From Baseline in QoL "Health Transition" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.'}, {'measure': 'Change From Baseline in QoL "Mental Health" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline score indicates improvement in mental health.'}, {'measure': 'Change From Baseline in QoL "Physical Functioning" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 24. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.'}, {'measure': 'Change From Baseline in QoL "Role Emotional" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 "role emotional" score at week 24. Scores could range from 0 to 100 with a higher score indicating a better QoL. Positive change from baseline scores indicate improvement in "role emotional."'}, {'measure': 'Change From Baseline in QoL "Role Physical" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.'}, {'measure': 'Change From Baseline in QoL "Social Functioning" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.'}, {'measure': 'Change From Baseline in QoL "Vitality" at Week 24', 'timeFrame': 'baseline and week 24', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 24. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.'}, {'measure': 'Change From Baseline in QoL at Week 52', 'timeFrame': 'baseline and week 52', 'description': 'Change from baseline in QoL was assessed using the SF-36 QoL questionnaire at week 52. Scores could range from 0 to 100 with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in QoL.'}, {'measure': 'Clinical Global Assessment of Efficacy', 'timeFrame': 'weeks 4, 24, and 52', 'description': 'Overall clinical efficacy was assessed by the Investigator using the following global ratings: very good, good, moderate, poor, or very poor, at weeks 4, 24, and 52.'}, {'measure': 'Change in Dose of Study Treatment', 'timeFrame': 'weeks 4, 24, and 52', 'description': 'Number of subjects with change in dose of study treatment was assessed at weeks 4, 24, and 52.'}, {'measure': 'Change in Dose of Study Treatment During Titration Phase (First 4 Weeks of Study) and Overall Treatment Phase I (First 24 Weeks of Study)', 'timeFrame': 'weeks 4 and 24', 'description': 'Number of subejcts with change in dose of study treatment was assessed and stratified by time on study, at least 4 weeks versus dropped out at highest dose before week 4, at weeks 4 and 24.'}, {'measure': 'Number of Drop-outs', 'timeFrame': 'baseline to week 24 (core); week 24 to week 52 (extension)', 'description': 'Number of drop-outs according to reasons for drop-out and due to inefficacy at maximal dosage was assessed at weeks 24 and 52.'}, {'measure': 'Number of Days With add-on Pain Medication', 'timeFrame': 'week 24', 'description': 'Number of days with add-on pain medication during the first 24 weeks of the study was assessed at week 24.'}, {'measure': 'Amount of add-on Pain Medication', 'timeFrame': '24 weeks', 'description': 'Total amount of add-on pain medication (paracetamol) for the first 24 weeks was assessed at week 24.'}, {'measure': 'Mode and Convenience of Drug Intake.', 'timeFrame': 'weeks 4, 24, and 52', 'description': 'Subjects filled out a questionnaire based on the mode and convenience of drug intake and could rate their responses as very convenient, convenient, neither convenient or inconvenient, inconvenient, and very inconvenient.'}, {'measure': 'Resource Utilization of Pain Management', 'timeFrame': 'week 24', 'description': 'Resource utilization was defined as the number of additional visits including additional telephone visits during the treatment period. This was assessed at week 24.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic noncancer pain', 'pain', 'analgesia', 'analgesic opioid', 'oxycodone', 'hydromorphone'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '20384968', 'type': 'RESULT', 'citation': 'Binsfeld H, Szczepanski L, Waechter S, Richarz U, Sabatowski R. A randomized study to demonstrate noninferiority of once-daily OROS((R)) hydromorphone with twice-daily sustained-release oxycodone for moderate to severe chronic noncancer pain. Pain Pract. 2010 Sep-Oct;10(5):404-15. doi: 10.1111/j.1533-2500.2009.00342.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness and safety of sustained- release hydromorphone, formulated to release slowly over time, taken once daily, and controlled- release oxycodone taken twice daily, in patients with chronic non-cancer pain. The study will also determine the dose of sustained-release hydromorphone that provides a level of pain control that is equal to the pain control provided by control-released oxycodone (equi-analgesic dosage).', 'detailedDescription': "Conventional immediate-release forms of hydromorphone and oxycodone have a relatively short duration of action that require dosing every 4 to 6 hours. To counterbalance the drawback of repeated opioid intake, sustained-release formulations of oxycodone and hydromorphone were developed that allow twice-daily dosing. Subsequently, a novel, once-daily, extended-release hydromorphone formulation was developed to further enhance ease of treatment and improve effectiveness in the treatment of severe pain. This is a randomized, open-label, comparative, parallel-group, 24-week flexible-dose study in patients with chronic noncancer pain severe enough to require continuous opioid therapy. Patients will receive either 8 mg of sustained-release hydromorphone, taken once daily or 10 mg of controlled-release oxycodone, taken twice daily. Individual adjustments in dosing will be performed to achieve satisfactory pain control, up to a maximum daily dosage of 32 mg for hydromorphone and 80 mg for oxycodone. The primary efficacy outcome will be the determination of the dose of hydromorphone that produces a level of pain control that is equal to the pain control provided by oxycodone (equi-analgesic dose). Safety will be monitored throughout the study. The study hypothesis is that sustained-release hydromorphone taken once daily is well tolerated and is not inferior with regard to pain control to controlled-release oxycodone taken twice daily.\n\nAmendment:\n\nAmendment was made to the duration of the study from duration of '24 weeks' to '52 weeks' in order to collect long-term safety and efficacy data. OROS hydromorphone 8, 16, or 32 mg tablets QD or SR oxycodone 10, 20, or 40 mg tablets BID. Individual adjustments in dosing performed to achieve satisfactory pain control over 24 weeks. Amendment: treatment duration was extended to 52 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with chronic noncancer pain severe enough to require continuous opioid therapy (a score of at least 5 in "pain right now" on a 11 point numeric rating scale) who have never received an opioid or are currently treated with a weak opioid, and who experience insufficient pain control.\n\nExclusion Criteria:\n\n* Patients who have been treated with strong opioids (including hydromorphone and oxycodone) within the last 4 weeks prior to study inclusion or who will probably undergo any treatment (e.g. neurological techniques, surgery) within the next 6 months, which may abruptly alter degree or nature of pain experienced\n* patients with a history of disease(s), current illness, or therapy which would preclude them from participation in the study\n* and patients who are pregnant or nursing.'}, 'identificationModule': {'nctId': 'NCT00261495', 'briefTitle': 'A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Pharmaceutica N.V., Belgium'}, 'officialTitle': 'Randomized, Open-Label, Comparative Parallel Group Study to Assess Efficacy and Safety on Flexible Dosages of OROS Hydromorphone Once-Daily Compared to Sustained Release Oxycodone Twice Daily in Subjects With Chronic Non-malignant Pain Requiring Continuous Opioid Therapy.', 'orgStudyIdInfo': {'id': 'CR002374'}, 'secondaryIdInfos': [{'id': 'OROS-ANA-3001', 'type': 'OTHER', 'domain': 'Janssen Pharmaceutica N.V.'}, {'id': '2004-005187-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxycodone', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'OROS hydromorphone HCl', 'interventionNames': ['Drug: OROS hydromorphone HCl']}], 'interventions': [{'name': 'OROS hydromorphone HCl', 'type': 'DRUG', 'description': '8 to 32 mg once daily for 52 weeks (flexible dosing)', 'armGroupLabels': ['OROS hydromorphone HCl']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': '10, 20, or 40 mg twice a day for 52 weeks (flexible dosing)', 'armGroupLabels': ['Oxycodone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Pilsen', 'country': 'Czechia', 'geoPoint': {'lat': 49.74747, 'lon': 13.37759}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Esbjerg', 'country': 'Denmark', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'city': 'Nyborg', 'country': 'Denmark', 'geoPoint': {'lat': 55.31274, 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{'city': 'Martin', 'country': 'Slovakia', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}, {'city': 'Prešov', 'country': 'Slovakia', 'geoPoint': {'lat': 48.99923, 'lon': 21.2355}}, {'city': 'Ljubljana', 'country': 'Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'city': 'Maribor', 'country': 'Slovenia', 'geoPoint': {'lat': 46.55583, 'lon': 15.64593}}, {'city': 'Slovenj Gradec', 'country': 'Slovenia', 'geoPoint': {'lat': 46.51088, 'lon': 15.08377}}, {'city': 'Gothenburg', 'country': 'Sweden', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'city': 'Jönköping', 'country': 'Sweden', 'geoPoint': {'lat': 57.78145, 'lon': 14.15618}}, {'city': 'Kristianstad', 'country': 'Sweden', 'geoPoint': {'lat': 56.03129, 'lon': 14.15242}}, {'city': 'Linköping', 'country': 'Sweden', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Aarau', 'country': 'Switzerland', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'city': 'Basel', 'country': 'Switzerland', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Lausanne', 'country': 'Switzerland', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Janssen Pharmaceutica N.V. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Pharmaceutica N.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Pharmaceutica N.V., Belgium', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}