Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-04 @ 12:36 AM
Study NCT ID:
NCT00694369
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2008-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)
Sponsor:
Organization:
Raw JSON
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Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse experiences were collected from the Pre-surgery/Pre-treatment period through the 14 day safety follow-up period.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo orally once daily', 'otherNumAtRisk': 46, 'otherNumAffected': 12, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Etoricoxib 90 mg', 'description': 'Etoricoxib 90 mg orally once daily', 'otherNumAtRisk': 191, 'otherNumAffected': 54, 'seriousNumAtRisk': 191, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Etoricoxib 120 mg', 'description': 'Etoricoxib 120 mg orally once daily', 'otherNumAtRisk': 97, 'otherNumAffected': 28, 'seriousNumAtRisk': 97, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ibuprofen 2400 mg', 'description': 'Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally', 'otherNumAtRisk': 192, 'otherNumAffected': 57, 'seriousNumAtRisk': 192, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Acetaminophen 2400 mg/Codeine 240 mg', 'description': 'Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally', 'otherNumAtRisk': 62, 'otherNumAffected': 35, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 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192, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 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'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Sensitivity of teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Alveolar osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Incision site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Oral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 191, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 97, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '62', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally once daily'}, {'id': 'OG001', 'title': 'Etoricoxib 90 mg', 'description': 'Etoricoxib 90 mg orally once daily'}, {'id': 'OG002', 'title': 'Etoricoxib 120 mg', 'description': 'Etoricoxib 120 mg orally once daily'}, {'id': 'OG003', 'title': 'Ibuprofen 2400 mg', 'description': 'Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally'}, {'id': 'OG004', 'title': 'Acetaminophen 2400 mg/Codeine 240 mg', 'description': 'Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally'}], 'classes': [{'categories': [{'measurements': [{'value': '5.08', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '16.10', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '15.73', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '15.67', 'spread': '0.42', 'groupId': 'OG003'}, {'value': '11.83', 'spread': '0.74', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': '0.05 critical level was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value\n\nfor 120-mg dose comparison is significant).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': '0.05 critical level was used.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '1.48', 'estimateComment': 'Difference in Least squares means (LS Means) (etoricoxib minus ibuprofen)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '1.60', 'estimateComment': 'Difference in LS Means (etoricoxib minus ibuprofen)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority bound (etoricoxib minus ibuprofen) is -4.45.'}, {'groupIds': ['OG002', 'OG004'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '3.90', 'ciLowerLimit': '2.04', 'ciUpperLimit': '5.76', 'estimateComment': 'Difference in LS Means (etoricoxib minus acetaminophen/codeine)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority bound (etoricoxib minus cetaminophen/codeine) is -2.41.'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '4.27', 'ciLowerLimit': '2.61', 'ciUpperLimit': '5.94', 'estimateComment': 'Difference in LS Means (etoricoxib minus acetaminophen/codeine)', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Non-inferiority bound (etoricoxib minus acetaminophen/codeine) is -2.41.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '1.05', 'estimateComment': 'Difference in LS Means (etoricoxib 120 mg minus etoricoxib 90 mg)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '10.59', 'ciLowerLimit': '8.72', 'ciUpperLimit': '12.47', 'estimateComment': 'Difference in LS Means (ibuprofen 2400 mg minus placebo)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Difference in LS Means', 'ciPctValue': '95', 'paramValue': '6.75', 'ciLowerLimit': '4.53', 'ciUpperLimit': '8.97', 'estimateComment': 'Difference in LS Means (acetaminophen 2400 mg/codeine 240 mg minus placebo)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Over the first 6 hours post the initial Day 1 dose of the study medication', 'description': 'TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline PR data over the first 6 hours). Observed PR was used up to rescue. Missing data was imputed by linear interpolation at time points before rescue, by last-observation-carried-forward at time points after rescue.'}, {'type': 'SECONDARY', 'title': "Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication", 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '180', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo orally once daily'}, {'id': 'OG001', 'title': 'Etoricoxib 90 mg', 'description': 'Etoricoxib 90 mg orally once daily'}, {'id': 'OG002', 'title': 'Etoricoxib 120 mg', 'description': 'Etoricoxib 120 mg orally once daily'}, {'id': 'OG003', 'title': 'Ibuprofen 2400 mg', 'description': 'Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally'}, {'id': 'OG004', 'title': 'Acetaminophen 2400 mg/Codeine 240 mg', 'description': 'Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally'}], 'classes': [{'title': 'Poor', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Fair', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'Very Good', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}]}, {'title': 'Excellent', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': '0.05 critical level was used.', 'statisticalMethod': 'stratified Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': '0.05 critical level was used.', 'statisticalMethod': 'stratified Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Step-down manner was used (p-value for 90-mg dose comparison was reported only if the p-value for 120-mg dose comparison is significant)'}, {'pValue': '0.161', 'groupIds': ['OG002', 'OG003'], 'ciPctValue': '95', 'pValueComment': '0.05 critical level was used.', 'statisticalMethod': 'stratified Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used, and the nominal p-value for 90-mg dose comparison was not reported.'}, {'pValue': '0.014', 'groupIds': ['OG002', 'OG004'], 'ciPctValue': '95', 'pValueComment': '0.05 critical level was used.', 'statisticalMethod': 'stratified Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.'}, {'pValue': '0.007', 'groupIds': ['OG001', 'OG004'], 'ciPctValue': '95', 'pValueComment': '0.05 critical level was used.', 'statisticalMethod': 'stratified Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Nominal p-value was provided in lieu of the 95% CI. Step-down manner was used.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 24 hours post the initial Day 1 dose of the study medication', 'description': "Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set population (all randomized patients who received at least 1 dose of study treatment and had at least 1 post-baseline assessment at 24 hours). Observed data was used. Forty patients were excluded from the analysis due to no measurement at 24 hours after the initial Day 1 dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo orally once daily'}, {'id': 'FG001', 'title': 'Etoricoxib 90 mg', 'description': 'Etoricoxib 90 mg orally once daily'}, {'id': 'FG002', 'title': 'Etoricoxib 120 mg', 'description': 'Etoricoxib 120 mg orally once daily'}, {'id': 'FG003', 'title': 'Ibuprofen 2400 mg', 'description': 'Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally'}, {'id': 'FG004', 'title': 'Acetaminophen 2400 mg/Codeine 240 mg', 'description': 'Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '191'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '192'}, {'groupId': 'FG004', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '188'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '189'}, {'groupId': 'FG004', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Study Conducted at 3 investigational sites in the US. Patients were recruited from the sites patient pool and through advertising. A total of 588 patients were randomized. First Patient Entered 27-June-2008; First Patient In (randomized) on 03-July- 2008; Last Patient Last Visit 08-Jan-09', 'preAssignmentDetails': 'Patients who met entry criteria and were experiencing moderate-to-severe pain after removal of at least 2\n\nthird molars (at least 1 being partially or completely impacted and of mandibular origin) were allocated to\n\nthe study. Wash-out period for exclusionary medication was specified in the protocol. Randomization was\n\nstratified by baseline pain.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}, {'value': '588', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo orally once daily'}, {'id': 'BG001', 'title': 'Etoricoxib 90 mg', 'description': 'Etoricoxib 90 mg orally once daily'}, {'id': 'BG002', 'title': 'Etoricoxib 120 mg', 'description': 'Etoricoxib 120 mg orally once daily'}, {'id': 'BG003', 'title': 'Ibuprofen 2400 mg', 'description': 'Ibuprofen 2400 mg (600 mg every 6 hours (Q6h)) orally'}, {'id': 'BG004', 'title': 'Acetaminophen 2400 mg/Codeine 240 mg', 'description': 'Acetaminophen 2400 mg/Codeine 240 mg (600/60 mg Q6h) orally'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '21.8', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '21.8', 'spread': '3.5', 'groupId': 'BG002'}, {'value': '21.6', 'spread': '3.8', 'groupId': 'BG003'}, {'value': '20.5', 'spread': '2.8', 'groupId': 'BG004'}, {'value': '21.5', 'spread': '3.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '340', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '248', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '142', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '432', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}, {'value': '532', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Pain Intensity', 'classes': [{'title': 'Moderate', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '304', 'groupId': 'BG005'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '284', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'description': 'The level of pain at baseline (before dosing) is indicated by the patient on the patient diary by placing a check mark next to the appropriate response to the following question (My starting pain is: None, Slight, Moderate, Severe). Patients who indicated moderate to severe pain at baseline were eligible to be\n\nrandomized into the study.', 'unitOfMeasure': 'Participants'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '71.21', 'spread': '16.33', 'groupId': 'BG000'}, {'value': '72.53', 'spread': '16.68', 'groupId': 'BG001'}, {'value': '71.02', 'spread': '15.96', 'groupId': 'BG002'}, {'value': '72.24', 'spread': '16.81', 'groupId': 'BG003'}, {'value': '69.43', 'spread': '13.99', 'groupId': 'BG004'}, {'value': '71.76', 'spread': '16.29', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Surgery', 'classes': [{'categories': [{'measurements': [{'value': '0.14', 'spread': '0.06', 'groupId': 'BG000'}, {'value': '0.13', 'spread': '0.06', 'groupId': 'BG001'}, {'value': '0.15', 'spread': '0.08', 'groupId': 'BG002'}, {'value': '0.14', 'spread': '0.06', 'groupId': 'BG003'}, {'value': '0.13', 'spread': '0.06', 'groupId': 'BG004'}, {'value': '0.14', 'spread': '0.06', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171.03', 'spread': '8.91', 'groupId': 'BG000'}, {'value': '168.39', 'spread': '9.95', 'groupId': 'BG001'}, {'value': '167.92', 'spread': '10.07', 'groupId': 'BG002'}, {'value': '168.50', 'spread': '9.05', 'groupId': 'BG003'}, {'value': '168.38', 'spread': '9.86', 'groupId': 'BG004'}, {'value': '168.56', 'spread': '9.59', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mean Impaction Score', 'classes': [{'categories': [{'measurements': [{'value': '2.41', 'spread': '0.51', 'groupId': 'BG000'}, {'value': '2.44', 'spread': '0.50', 'groupId': 'BG001'}, {'value': '2.40', 'spread': '0.52', 'groupId': 'BG002'}, {'value': '2.50', 'spread': '0.48', 'groupId': 'BG003'}, {'value': '2.40', 'spread': '0.51', 'groupId': 'BG004'}, {'value': '2.45', 'spread': '0.50', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'description': 'Impaction Score (Soft Tissue =1, Partial Embedded= 2,\n\nEmbedded = 3)', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Hours from End of Surgery to Dosing', 'classes': [{'categories': [{'measurements': [{'value': '3.06', 'spread': '0.79', 'groupId': 'BG000'}, {'value': '2.94', 'spread': '0.77', 'groupId': 'BG001'}, {'value': '2.84', 'spread': '0.75', 'groupId': 'BG002'}, {'value': '3.01', 'spread': '0.84', 'groupId': 'BG003'}, {'value': '2.97', 'spread': '0.78', 'groupId': 'BG004'}, {'value': '2.96', 'spread': '0.79', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Hours', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of Teeth Removed', 'classes': [{'categories': [{'measurements': [{'value': '2.04', 'spread': '0.29', 'groupId': 'BG000'}, {'value': '2.06', 'spread': '0.27', 'groupId': 'BG001'}, {'value': '2.10', 'spread': '0.39', 'groupId': 'BG002'}, {'value': '2.02', 'spread': '0.12', 'groupId': 'BG003'}, {'value': '2.03', 'spread': '0.18', 'groupId': 'BG004'}, {'value': '2.05', 'spread': '0.26', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Teeth', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 588}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2008-06-06', 'resultsFirstSubmitDate': '2009-11-13', 'studyFirstSubmitQcDate': '2008-06-09', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-01-04', 'studyFirstPostDateStruct': {'date': '2008-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)', 'timeFrame': 'Over the first 6 hours post the initial Day 1 dose of the study medication', 'description': 'TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.'}], 'secondaryOutcomes': [{'measure': "Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication", 'timeFrame': 'At 24 hours post the initial Day 1 dose of the study medication', 'description': "Patient's Global Assessment of Study Medication was on 0- to 4- point scale, with 0=Poor, and 4=Excellent for patient's rating of the study medication for pain."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postoperative Dental Pain'], 'conditions': ['Postoperative Dental Pain']}, 'referencesModule': {'references': [{'pmid': '23247002', 'type': 'DERIVED', 'citation': 'Brown JD, Daniels SE, Bandy DP, Ko AT, Gammaitoni A, Mehta A, Boice JA, Losada MC, Peloso PM. Evaluation of multiday analgesia with etoricoxib in a double-blind, randomized controlled trial using the postoperative third-molar extraction dental pain model. Clin J Pain. 2013 Jun;29(6):492-8. doi: 10.1097/AJP.0b013e318260c144.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw\n* Patients must be experiencing moderate to severe pain following the dental procedure\n\nExclusion Criteria:\n\n* Previous molar extraction within the past 45 days\n* Personal or family history of an inherited bleeding disorder\n* Uncontrolled high blood pressure'}, 'identificationModule': {'nctId': 'NCT00694369', 'briefTitle': 'A Study to Asses the Effect of MK0663 in the Treatment of Patients With Postoperative Dental Pain (0663-092)', '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 Efficacy and Safety of MK0663/Etoricoxib 90 and 120 mg, Ibuprofen 600 mg, and Acetaminophen 600 mg/Codeine 60 mg in the Treatment of Patients With Postoperative Dental Pain', 'orgStudyIdInfo': {'id': '0663-092'}, 'secondaryIdInfos': [{'id': 'MK0663-092'}, {'id': '2008_506'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'etoricoxib 90 mg', 'interventionNames': ['Drug: Comparator: etoricoxib']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'etoricoxib 120 mg', 'interventionNames': ['Drug: Comparator: etoricoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'ibuprofen 2400 mg', 'interventionNames': ['Drug: Comparator: ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': 'acetaminophen 2400 mg/codeine 240 mg', 'interventionNames': ['Drug: Comparator: acetaminophen + codeine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '5', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Comparator: placebo']}], 'interventions': [{'name': 'Comparator: etoricoxib', 'type': 'DRUG', 'description': 'etoricoxib 90 mg; 120 mg (once daily) over three days.', 'armGroupLabels': ['1', '2']}, {'name': 'Comparator: ibuprofen', 'type': 'DRUG', 'description': 'ibuprofen 2400 mg (600 mg Q6h) over three Days', 'armGroupLabels': ['3']}, {'name': 'Comparator: acetaminophen + codeine', 'type': 'DRUG', 'description': 'acetaminophen 2400 mg/codeine 240 mg (600/60 mg Q6h) over three Days', 'armGroupLabels': ['4']}, {'name': 'Comparator: placebo', 'type': 'DRUG', 'description': 'matching placebo over three Days', 'armGroupLabels': ['5']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}