Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT00820027
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2009-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Costa Rica', 'Czechia', 'Estonia', 'Germany', 'Hungary', 'Lithuania', 'Norway', 'Philippines', 'Singapore', 'Slovenia', 'South Africa', 'South Korea', 'Taiwan', 'Turkey (Türkiye)', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077613', 'term': 'Etoricoxib'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D009020', 'term': 'Morphine'}, {'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'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'}, {'id': 'D003061', 'term': 'Codeine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 21 days post surgery', 'description': 'The analysis population consisted of all randomized patients who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 57, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 110, 'seriousNumAtRisk': 222, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 116, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Ibuprofen 1800mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.', 'otherNumAtRisk': 223, 'deathsNumAtRisk': 223, 'otherNumAffected': 108, 'seriousNumAtRisk': 223, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 37, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 63, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 78, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 70, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 43, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 37, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 25, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peptic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 98, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 230, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.93', 'groupId': 'OG000', 'lowerLimit': '-4.17', 'upperLimit': '-3.69'}, {'value': '-3.87', 'groupId': 'OG001', 'lowerLimit': '-4.11', 'upperLimit': '-3.64'}, {'value': '-3.39', 'groupId': 'OG002', 'lowerLimit': '-3.74', 'upperLimit': '-3.04'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '-0.08', 'statisticalMethod': 'longitudinal data analysis (LDA)', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '-0.14', 'statisticalMethod': 'LDA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimate from LDA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Days 1-3', 'description': 'The pain intensity difference was measured at rest over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) compared to placebo for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to placebo was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints \\[Pain Intensity Difference (PID) and Morphine\\] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the ibuprofen arm was not included in this outcome measure."}, {'type': 'PRIMARY', 'title': 'Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.87', 'groupId': 'OG000', 'lowerLimit': '7.88', 'upperLimit': '9.97'}, {'value': '9.25', 'groupId': 'OG001', 'lowerLimit': '8.26', 'upperLimit': '10.40'}, {'value': '13.40', 'groupId': 'OG002', 'lowerLimit': '11.20', 'upperLimit': '16.00'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Between-Treatment Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.85', 'estimateComment': 'A ratio \\<1 indicates a beneficial effect of Etoricoxib.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Between-Treatment Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.82', 'estimateComment': 'A ratio \\<1 indicates a beneficial effect of Etoricoxib.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1-3', 'description': 'The average total dose of morphine was assessed when participant received etoricoxib 120 milligram(mg)/90 mg compared to placebo. Opioids taken were converted to mg morphine equivalents according to the following conventions: 1 mg morphine sulphate=1 mg morphine,1 mg morphine hydrochloride=1.17 mg morphine. A 5 mg oxycodone tablet=2.5 mg morphine,12.5 mg meperidine =1.67 mg morphine. Least-squares mean back-transformed; estimate obtained from longitudinal analysis of variance (ANOVA) model on log-transformed morphine dose with terms for baseline pain intensity(moderate or severe),type of anesthesia (spinal, general), treatment, day, and the interaction of day by treatment.', 'unitOfMeasure': 'milligrams (mg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by PCA. Per protocol, the ibuprofen arm was not included in this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.506', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '2.5', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '1.7', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '>0.999', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '1.7', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.316', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '2.5', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '>0.999', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '1.7', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '>0.999', 'groupIds': ['OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.8', 'groupDescription': 'Placebo vs. Ibuprofen 1800 mg', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.309', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '1.2', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized patients who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Edema-Related AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}, {'value': '1.8', 'groupId': 'OG002'}, {'value': '4.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.054', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-9.2', 'ciUpperLimit': '0.1', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.209', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '1.2', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.227', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '1.3', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.415', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '1.6', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.965', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-3.0', 'ciUpperLimit': '2.8', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.227', 'groupIds': ['OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.3', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '8.4', 'groupDescription': 'Placebo vs. Ibuprofen 1800 mg', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '3.6', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. Edema is swelling caused by excess fluid trapped in body tissues.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized patients who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Hypertension-Related AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}, {'value': '3.1', 'groupId': 'OG002'}, {'value': '3.1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.806', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '4.5', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.278', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-7.4', 'ciUpperLimit': '1.4', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.971', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-5.7', 'ciUpperLimit': '3.9', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.786', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.5', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '4.2', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.184', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '1.0', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.971', 'groupIds': ['OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '5.7', 'groupDescription': 'Placebo vs. Ibuprofen 1800 mg', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '0.6', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized patients who received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least One Opioid-Related AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000'}, {'value': '36.5', 'groupId': 'OG001'}, {'value': '36.3', 'groupId': 'OG002'}, {'value': '41.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.365', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.3', 'ciLowerLimit': '-17.0', 'ciUpperLimit': '6.0', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.222', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in Percent', 'ciPctValue': '95', 'paramValue': '-7.2', 'ciLowerLimit': '-18.8', 'ciUpperLimit': '4.2', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.349', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-17.2', 'ciUpperLimit': '5.9', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.965', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '9.0', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.718', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-10.5', 'ciUpperLimit': '7.3', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.349', 'groupIds': ['OG003'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '17.2', 'groupDescription': 'Placebo vs. Ibuprofen 1800 mg', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.684', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percent', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '10.6', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 21 days', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. Opioid-related AEs include nausea, vomiting, constipation, somnolence, respiratory depression, urinary retention and ileus.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized patients who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.93', 'groupId': 'OG000', 'lowerLimit': '-4.17', 'upperLimit': '-3.69'}, {'value': '-3.87', 'groupId': 'OG001', 'lowerLimit': '-4.11', 'upperLimit': '-3.64'}, {'value': '-3.83', 'groupId': 'OG002', 'lowerLimit': '-4.07', 'upperLimit': '-3.59'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Least Squares Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.27', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.22', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority reached if the upper bound of the 95% confidence interval of the between-treatment difference (Etoricoxib minus Ibuprofen) in LS means is no greater than 1.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Days 1-3', 'description': 'The pain intensity difference was measured at rest over Days 1 through 3 in participants treated with etoricoxib (120 mg, 90 mg) compared to ibuprofen for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to ibuprofen was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints \\[Pain Intensity Difference (PID) and morphine\\] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the placebo arm was not included in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '225', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.87', 'groupId': 'OG000', 'lowerLimit': '7.88', 'upperLimit': '9.97'}, {'value': '9.25', 'groupId': 'OG001', 'lowerLimit': '8.26', 'upperLimit': '10.4'}, {'value': '8.82', 'groupId': 'OG002', 'lowerLimit': '7.85', 'upperLimit': '9.91'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Between-Treatment Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.23', 'estimateComment': 'A ratio \\<1 indicates a beneficial effect of Etoricoxib.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Between-Treatment Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.85', 'ciUpperLimit': '1.18', 'estimateComment': 'A ratio \\<1 indicates a beneficial effect of Etoricoxib.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Between-Treatment Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.23', 'estimateComment': 'A ratio \\<1 indicates a beneficial effect of Etoricoxib.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Estimate from ANOVA model with terms for baseline pain intensity, type of anesthesia, treatment, day, and interaction of day by treatment.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1-3', 'description': 'The difference in average total daily dose of morphine used over Days 1 through 3 between participants treated with etoricoxib (120 mg, 90 mg) or ibuprofen 1800 mg (administered as 600 mg three times daily, every 8 hours) in the treatment of pain following total knee replacement orthopedic surgery was assessed. Opioids taken were converted to mg morphine equivalents according to the following conventions:1 mg morphine sulphate = 1 mg morphine, 1 mg morphine hydrochloride = 1.17 mg morphine. A 5 mg oxycodone tablet = 2.5 mg morphine,12.5 mg meperidine = 1.67 mg morphine.', 'unitOfMeasure': 'milligrams (mg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "All randomized participants, excluding those who didn't receive at least 1 dose of study treatment, lacked 1 post-randomization measurement, were randomized at a specific site, or received continuous infusion of morphine by patient control analgesia (PCA). Per protocol, the placebo arm was not included in this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}, {'value': '223', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'OG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}, {'value': '4.5', 'groupId': 'OG002'}, {'value': '5.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all randomized patients who received at least one dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'FG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'FG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '230'}, {'groupId': 'FG002', 'numSubjects': '224'}, {'groupId': 'FG003', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '203'}, {'groupId': 'FG003', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '776', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'BG001', 'title': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.'}, {'id': 'BG002', 'title': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '8.5', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '66.0', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '65.2', 'spread': '7.9', 'groupId': 'BG003'}, {'value': '65.4', 'spread': '8.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '481', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '295', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}, {'value': '766', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '693', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 776}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2010-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2009-01-07', 'resultsFirstSubmitDate': '2020-03-23', 'studyFirstSubmitQcDate': '2009-01-07', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-23', 'studyFirstPostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Placebo)', 'timeFrame': 'Baseline and Days 1-3', 'description': 'The pain intensity difference was measured at rest over Days 1 through 3 in patients treated with etoricoxib (120 mg, 90 mg) compared to placebo for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to placebo was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints \\[Pain Intensity Difference (PID) and Morphine\\] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.'}, {'measure': 'Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Placebo)', 'timeFrame': 'Days 1-3', 'description': 'The average total dose of morphine was assessed when participant received etoricoxib 120 milligram(mg)/90 mg compared to placebo. Opioids taken were converted to mg morphine equivalents according to the following conventions: 1 mg morphine sulphate=1 mg morphine,1 mg morphine hydrochloride=1.17 mg morphine. A 5 mg oxycodone tablet=2.5 mg morphine,12.5 mg meperidine =1.67 mg morphine. Least-squares mean back-transformed; estimate obtained from longitudinal analysis of variance (ANOVA) model on log-transformed morphine dose with terms for baseline pain intensity(moderate or severe),type of anesthesia (spinal, general), treatment, day, and the interaction of day by treatment.'}, {'measure': 'Percentage of Participants With at Least One Adverse Event of Congestive Heart Failure, Pulmonary Edema, or Cardiac Failure', 'timeFrame': 'Up to 21 days', 'description': 'An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.'}, {'measure': 'Percentage of Participants With at Least One Edema-Related AE', 'timeFrame': 'Up to 21 days', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. Edema is swelling caused by excess fluid trapped in body tissues.'}, {'measure': 'Percentage of Participants With at Least One Hypertension-Related AE', 'timeFrame': 'Up to 21 days', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.'}, {'measure': 'Percentage of Participants With at Least One Opioid-Related AE', 'timeFrame': 'Up to 21 days', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE. Opioid-related AEs include nausea, vomiting, constipation, somnolence, respiratory depression, urinary retention and ileus.'}, {'measure': 'Percentage of Participants Who Discontinued Study Drug Due to an AE', 'timeFrame': 'Up to 7 days', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study product, is also an AE.'}], 'secondaryOutcomes': [{'measure': 'Average Change From Baseline for Pain Intensity at Rest Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)', 'timeFrame': 'Baseline and Days 1-3', 'description': 'The pain intensity difference was measured at rest over Days 1 through 3 in participants treated with etoricoxib (120 mg, 90 mg) compared to ibuprofen for the treatment of pain following total knee replacement orthopedic surgery. Pain intensity difference at rest was measured on a numerical rating scale (NRS) from 0 - 10 points (0=no pain, to 10=pain as bad as you can imagine). Comparison to ibuprofen was conducted in a step-down manner (the 90-mg dose was evaluated only if the null hypotheses for co-primary endpoints \\[Pain Intensity Difference (PID) and morphine\\] 120-mg doses were rejected). The primary analyses for change from baseline in average pain intensity at rest over Days 1 to 3 was performed using the longitudinal data analysis (LDA) method with the terms for baseline pain intensity (moderate or severe), type of anesthesia (spinal or general), treatment, day, and the interaction of day by treatment.'}, {'measure': 'Average Total Daily Dose of Postoperative Morphine Over Days 1 to 3 (Etoricoxib vs. Ibuprofen)', 'timeFrame': 'Days 1-3', 'description': 'The difference in average total daily dose of morphine used over Days 1 through 3 between participants treated with etoricoxib (120 mg, 90 mg) or ibuprofen 1800 mg (administered as 600 mg three times daily, every 8 hours) in the treatment of pain following total knee replacement orthopedic surgery was assessed. Opioids taken were converted to mg morphine equivalents according to the following conventions:1 mg morphine sulphate = 1 mg morphine, 1 mg morphine hydrochloride = 1.17 mg morphine. A 5 mg oxycodone tablet = 2.5 mg morphine,12.5 mg meperidine = 1.67 mg morphine.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '24156640', 'type': 'DERIVED', 'citation': 'Rawal N, Viscusi E, Peloso PM, Minkowitz HS, Chen L, Shah S, Mehta A, Chitkara DK, Curtis SP, Papanicolaou DA. Evaluation of etoricoxib in patients undergoing total knee replacement surgery in a double-blind, randomized controlled trial. BMC Musculoskelet Disord. 2013 Oct 24;14:300. doi: 10.1186/1471-2474-14-300.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy and safety of Etoricoxib compared to placebo and ibuprofen in the treatment of postoperative pain associated with unilateral total knee replacement surgery. The hypotheses for this study were that the average pain intensity difference (at rest) in participants treated with Etoricoxib (120 mg, 90 mg) is superior to placebo, the average total daily dose of morphine in participants treated with Etoricoxib (120 mg, 90 mg) is less than in participants treated with placebo, and that Etoricoxib (120 mg, 90 mg) will be generally safe and well tolerated by participants treated for pain following total knee replacement orthopedic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Is in generally good health and is scheduled to have a total knee replacement\n\nExclusion Criteria:\n\n* Is allergic, intolerant to, or has a history of a significant clinical or laboratory adverse experience associated with etoricoxib or other cyclooxygenase-2 (COX-2) inhibitors/non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen, morphine, or oxycodone, or has hypersensitivity to aspirin, or other NSAIDs\n* Has uncontrolled hypertension\n* Is currently a user of any illicit drugs, or has a history of drug or alcohol abuse within the past 5 years'}, 'identificationModule': {'nctId': 'NCT00820027', 'briefTitle': 'Study of MK-0663/Etoricoxib in Postorthopedic Knee Replacement Surgery Pain (MK-0663-098)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Multiple-Dose, Clinical Trial to Study the Safety and Efficacy of MK0663/Etoricoxib and Ibuprofen in the Treatment of Postorthopedic Knee Replacement Surgery Pain', 'orgStudyIdInfo': {'id': '0663-098'}, 'secondaryIdInfos': [{'id': '2009_502', 'type': 'OTHER', 'domain': 'Merck Registration Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etoricoxib 90 mg', 'description': 'Participants received etoricoxib 90 mg once daily, matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.', 'interventionNames': ['Drug: Etoricoxib 90 mg', 'Drug: Matching Placebo for Etoricoxib 120 mg', 'Drug: Matching Placebo for Ibuprofen', 'Drug: Morphine', 'Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Etoricoxib 120 mg', 'description': 'Participants received etoricoxib 120 mg once daily, matching placebo to etoricoxib 90 mg once daily, and matching placebo to ibuprofen 600 mg every 8 hours for 7 days.', 'interventionNames': ['Drug: Etoricoxib 120 mg', 'Drug: Matching Placebo for Etoricoxib 90 mg', 'Drug: Matching Placebo for Ibuprofen', 'Drug: Morphine', 'Drug: Oxycodone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen 1800 mg', 'description': 'Participants received ibuprofen 600 mg every 8 hours, matching placebo to etoricoxib 120 mg once daily, and matching placebo to etoricoxib 90 mg once daily for 7 days.', 'interventionNames': ['Drug: Ibuprofen 600 mg', 'Drug: Matching Placebo for Etoricoxib 120 mg', 'Drug: Matching Placebo for Etoricoxib 90 mg', 'Drug: Morphine', 'Drug: Oxycodone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received matching placebo to etoricoxib 90 mg and matching placebo to etoricoxib 120 mg once daily, and matching placebo to ibuprofen every 8 hours for 7 days.', 'interventionNames': ['Drug: Matching Placebo for Etoricoxib 120 mg', 'Drug: Matching Placebo for Etoricoxib 90 mg', 'Drug: Matching Placebo for Ibuprofen', 'Drug: Morphine', 'Drug: Oxycodone']}], 'interventions': [{'name': 'Etoricoxib 90 mg', 'type': 'DRUG', 'otherNames': ['MK-0663'], 'description': 'One 90 mg tablet once daily', 'armGroupLabels': ['Etoricoxib 90 mg']}, {'name': 'Etoricoxib 120 mg', 'type': 'DRUG', 'otherNames': ['MK-0663'], 'description': 'Two 60 mg tablets once daily', 'armGroupLabels': ['Etoricoxib 120 mg']}, {'name': 'Ibuprofen 600 mg', 'type': 'DRUG', 'description': 'One tablet three times daily', 'armGroupLabels': ['Ibuprofen 1800 mg']}, {'name': 'Matching Placebo for Etoricoxib 120 mg', 'type': 'DRUG', 'description': 'Two tablets once daily', 'armGroupLabels': ['Etoricoxib 90 mg', 'Ibuprofen 1800 mg', 'Placebo']}, {'name': 'Matching Placebo for Etoricoxib 90 mg', 'type': 'DRUG', 'description': 'One tablet once daily', 'armGroupLabels': ['Etoricoxib 120 mg', 'Ibuprofen 1800 mg', 'Placebo']}, {'name': 'Matching Placebo for Ibuprofen', 'type': 'DRUG', 'description': 'One tablet three times daily', 'armGroupLabels': ['Etoricoxib 120 mg', 'Etoricoxib 90 mg', 'Placebo']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'As needed via patient-controlled analgesia (PCA) device or as a bolus intravenous injection', 'armGroupLabels': ['Etoricoxib 120 mg', 'Etoricoxib 90 mg', 'Ibuprofen 1800 mg', 'Placebo']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': '5 mg as needed', 'armGroupLabels': ['Etoricoxib 120 mg', 'Etoricoxib 90 mg', 'Ibuprofen 1800 mg', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}