Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT01147458
Status:
TERMINATED
Last Update Posted:
2013-06-06
First Post:
2010-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009288', 'term': 'Naproxen'}], 'ancestors': [{'id': 'D009280', 'term': 'Naphthaleneacetic Acids'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to increases in hepatic enzymes for which a relationship to study drug could not be excluded and that could alter the potential benefit-risk for participants continuing in the study.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04191834', 'description': 'PF-04191834 600 mg BID administered either in Period 1 or Period 2', 'otherNumAtRisk': 79, 'otherNumAffected': 35, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo administered either in Period 1 or Period 2', 'otherNumAtRisk': 81, 'otherNumAffected': 43, 'seriousNumAtRisk': 81, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PF-04191834 + Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2', 'otherNumAtRisk': 81, 'otherNumAffected': 39, 'seriousNumAtRisk': 81, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Naproxen', 'description': 'Naproxen 500 mg BID administered either in Period 1 or Period 2', 'otherNumAtRisk': 83, 'otherNumAffected': 42, 'seriousNumAtRisk': 83, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Nodal arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Conjuctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Eye penetration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 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'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 79, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 81, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 83, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.3', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '2.81', 'groupId': 'OG001'}, {'value': '10.8', 'spread': '2.60', 'groupId': 'OG002'}, {'value': '11.1', 'spread': '2.93', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '3.10', 'groupId': 'OG001'}, {'value': '-1.9', 'spread': '2.97', 'groupId': 'OG002'}, {'value': '-1.6', 'spread': '2.93', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.56', 'ciLowerLimit': '0.08', 'ciUpperLimit': '1.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.374', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.701', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.20', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.369', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)', 'description': 'The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.7', 'spread': '3.53', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '3.15', 'groupId': 'OG001'}, {'value': '9.7', 'spread': '2.74', 'groupId': 'OG002'}, {'value': '10.2', 'spread': '3.47', 'groupId': 'OG003'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.44', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '3.64', 'groupId': 'OG002'}, {'value': '-2.1', 'spread': '3.03', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.56', 'ciLowerLimit': '0.08', 'ciUpperLimit': '1.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.374', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.701', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.20', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.369', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)', 'description': 'The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.'}, {'type': 'SECONDARY', 'title': 'WOMAC Stiffness Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Period 1 Baseline', 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.41', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '1.42', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '1.47', 'groupId': 'OG003'}]}]}, {'title': 'Period 1 End of Treatment', 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '1.36', 'groupId': 'OG002'}, {'value': '4.0', 'spread': '1.55', 'groupId': 'OG003'}]}]}, {'title': 'Period 2 Baseline', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.33', 'groupId': 'OG001'}, {'value': '3.9', 'spread': '1.44', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '1.41', 'groupId': 'OG003'}]}]}, {'title': 'Period 2 End of Treatment', 'categories': [{'measurements': [{'value': '3.3', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.38', 'groupId': 'OG001'}, {'value': '2.9', 'spread': '1.31', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '1.74', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.07', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.172', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.13', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.35', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.170', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2', 'description': 'The WOMAC Stiffness subscale, comprised of 2 questions regarding the amount of stiffness experienced in the index joint, was calculated as the mean of the scores from the 2 individual questions. The WOMAC Stiffness subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-8, with higher scores indicating more stiffness.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.'}, {'type': 'SECONDARY', 'title': 'WOMAC Physical Function Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Period 1 Baseline', 'categories': [{'measurements': [{'value': '37.7', 'spread': '9.39', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '10.27', 'groupId': 'OG001'}, {'value': '37.4', 'spread': '8.50', 'groupId': 'OG002'}, {'value': '38.7', 'spread': '10.43', 'groupId': 'OG003'}]}]}, {'title': 'Period 1 End of Treatment', 'categories': [{'measurements': [{'value': '35.4', 'spread': '9.60', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '10.01', 'groupId': 'OG001'}, {'value': '30.8', 'spread': '11.30', 'groupId': 'OG002'}, {'value': '32.0', 'spread': '13.43', 'groupId': 'OG003'}]}]}, {'title': 'Period 2 Baseline', 'categories': [{'measurements': [{'value': '32.6', 'spread': '12.37', 'groupId': 'OG000'}, {'value': '31.6', 'spread': '9.64', 'groupId': 'OG001'}, {'value': '31.6', 'spread': '10.70', 'groupId': 'OG002'}, {'value': '35.6', 'spread': '11.46', 'groupId': 'OG003'}]}]}, {'title': 'Period 2 End of Treatment', 'categories': [{'measurements': [{'value': '27.9', 'spread': '13.11', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '11.02', 'groupId': 'OG001'}, {'value': '25.0', 'spread': '10.75', 'groupId': 'OG002'}, {'value': '28.7', 'spread': '14.95', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.26', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '2.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.239', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.34', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '1.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.252', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2', 'description': "The WOMAC Physical Function subscale refers to the participant's ability to move around and perform usual activities of daily living. The WOMAC Physical Function subscale, comprised of 17 questions regarding the degree of difficulty experienced in the index joint, was calculated as the mean of the scores from the 17 individual questions. The WOMAC Physical Function subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-68, with higher scores indicating worse function.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.'}, {'type': 'SECONDARY', 'title': 'WOMAC Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Period 1 Baseline', 'categories': [{'measurements': [{'value': '53.7', 'spread': '11.96', 'groupId': 'OG000'}, {'value': '56.0', 'spread': '13.49', 'groupId': 'OG001'}, {'value': '52.9', 'spread': '11.57', 'groupId': 'OG002'}, {'value': '54.8', 'spread': '14.05', 'groupId': 'OG003'}]}]}, {'title': 'Period 1 End of Treatment', 'categories': [{'measurements': [{'value': '50.0', 'spread': '12.60', 'groupId': 'OG000'}, {'value': '49.9', 'spread': '14.16', 'groupId': 'OG001'}, {'value': '43.5', 'spread': '14.96', 'groupId': 'OG002'}, {'value': '45.4', 'spread': '18.54', 'groupId': 'OG003'}]}]}, {'title': 'Period 2 Baseline', 'categories': [{'measurements': [{'value': '46.4', 'spread': '16.94', 'groupId': 'OG000'}, {'value': '44.2', 'spread': '13.62', 'groupId': 'OG001'}, {'value': '45.1', 'spread': '14.37', 'groupId': 'OG002'}, {'value': '50.3', 'spread': '15.96', 'groupId': 'OG003'}]}]}, {'title': 'Period 2 End of Treatment', 'categories': [{'measurements': [{'value': '39.4', 'spread': '18.13', 'groupId': 'OG000'}, {'value': '42.6', 'spread': '15.73', 'groupId': 'OG001'}, {'value': '35.4', 'spread': '14.32', 'groupId': 'OG002'}, {'value': '40.6', 'spread': '20.99', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.06', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '4.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.699', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.33', 'ciLowerLimit': '-2.53', 'ciUpperLimit': '1.88', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.709', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2', 'description': 'The WOMAC total score was calculated as the sum of Pain subscale score (5 questions), Stiffness subscale score (2 questions) and Physical Function subscale score (17 questions), with a total of 24 questions(score range:0=none, 4=extreme) giving a possible total score range from 0 to 96 . lower subscale scores represent less pain, less stiffness, or better physical performance.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.'}, {'type': 'SECONDARY', 'title': 'Importance Weighted Total WOMAC Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Period 1 Baseline', 'categories': [{'measurements': [{'value': '19.7', 'spread': '4.38', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '4.94', 'groupId': 'OG001'}, {'value': '19.4', 'spread': '4.26', 'groupId': 'OG002'}, {'value': '20.1', 'spread': '5.17', 'groupId': 'OG003'}]}]}, {'title': 'Period 1 End of Treatment', 'categories': [{'measurements': [{'value': '18.3', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '5.22', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '5.51', 'groupId': 'OG002'}, {'value': '16.6', 'spread': '6.82', 'groupId': 'OG003'}]}]}, {'title': 'Period 2 Baseline', 'categories': [{'measurements': [{'value': '17.0', 'spread': '6.23', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '5.03', 'groupId': 'OG001'}, {'value': '16.6', 'spread': '5.25', 'groupId': 'OG002'}, {'value': '18.4', 'spread': '5.88', 'groupId': 'OG003'}]}]}, {'title': 'Period 2 End of Treatment', 'categories': [{'measurements': [{'value': '14.4', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '5.79', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '5.29', 'groupId': 'OG002'}, {'value': '14.9', 'spread': '7.71', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.77', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '1.58', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.624', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.16', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '0.65', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.628', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2', 'description': 'Importance weighted total WOMAC score was calculated using all subscales including Pain, Stiffness and Physical Function subscales (24 questions in total,score range: 0=none to 4= extreme,giving a possible overall score range of 0-96).Lower subscale scores represent less pain, less stiffness, or better physical performance.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.'}, {'type': 'SECONDARY', 'title': 'Daily Diary Pain Score During Week 1 of Each Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Baseline of Period 1', 'categories': [{'measurements': [{'value': '6.5', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '1.55', 'groupId': 'OG003'}]}]}, {'title': 'Week 1 of Period 1', 'categories': [{'measurements': [{'value': '6.2', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.52', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '1.80', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '2.05', 'groupId': 'OG003'}]}]}, {'title': 'Baseline of Period 2', 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '1.85', 'groupId': 'OG003'}]}]}, {'title': 'Week 1 of Period 2', 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.27', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.48', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '1.87', 'groupId': 'OG002'}, {'value': '5.0', 'spread': '2.04', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.01', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.150', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.12', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.147', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits', 'description': 'The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.'}, {'type': 'SECONDARY', 'title': 'Daily Diary Pain Score During Week 2 of Each Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Baseline of Period 1', 'categories': [{'measurements': [{'value': '6.5', 'spread': '1.56', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '1.36', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '6.7', 'spread': '1.55', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 of Period 1', 'categories': [{'measurements': [{'value': '5.8', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.72', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '1.66', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '2.16', 'groupId': 'OG003'}]}]}, {'title': 'Baseline of Period 2', 'categories': [{'measurements': [{'value': '5.1', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '5.4', 'spread': '1.69', 'groupId': 'OG002'}, {'value': '5.6', 'spread': '1.85', 'groupId': 'OG003'}]}]}, {'title': 'Week 2 of Period 2', 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.44', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '2.58', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '1.68', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '2.18', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.09', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.168', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.10', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.162', 'groupDescription': 'The analysis was a mixed model with random participant effect, period and treatment as fixed effects, utilizing the baseline scores (one for each treatment period) as inter- and intra- participant covariates.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2', 'description': 'The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): included all participants randomized who received at least one dose of study drug, regardless of whether they had efficacy data.'}, {'type': 'SECONDARY', 'title': 'Rescue Medication Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'classes': [{'title': 'Period 1', 'categories': [{'measurements': [{'value': '1096.1', 'spread': '310.59', 'groupId': 'OG000'}, {'value': '1114.5', 'spread': '367.92', 'groupId': 'OG001'}, {'value': '1210.2', 'spread': '442.70', 'groupId': 'OG002'}, {'value': '1073.7', 'spread': '409.83', 'groupId': 'OG003'}]}]}, {'title': 'Period 2', 'categories': [{'measurements': [{'value': '1100.0', 'spread': '528.15', 'groupId': 'OG000'}, {'value': '1078.1', 'spread': '200.62', 'groupId': 'OG001'}, {'value': '980.8', 'spread': '360.29', 'groupId': 'OG002'}, {'value': '932.7', 'spread': '263.27', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -7 (Visit 2) up to 28-day follow-up (Visit 10)', 'description': 'Rescue medication use was collected daily in a daily diary, in which participants noted the amount of rescue medication (number of pills) taken each day. Participants were provided with rescue medication paracetamol/acetaminophen throughout the study including the Washout Period and the Initial Pain Assessment Period. Paracetamol/acetaminophen was taken as needed to a maximum of 2000 mg per day, but must be discontinued 48 hours prior to the Baseline visit (Visit 3). From Visit 3 onwards, participants might take up to 2000 mg of paracetamol/acetaminophen per day up to 3 days per week.', 'unitOfMeasure': 'Number of pills', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of subjects analyzed (N) is the number of participants taking rescue mediation.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of PF-04191834', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 600 mg BID', 'description': 'PF-04191834 600 mg BID administered either in Period 1 or Period 2'}, {'id': 'OG001', 'title': 'PF-04191834 600 mg BID + Naproxen 500 mg BID', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2'}], 'classes': [{'title': 'Period 1 Day 1 Post-dose', 'categories': [{'measurements': [{'value': '121.5', 'spread': '7.7782', 'groupId': 'OG000'}, {'value': '214.8', 'spread': '280.61', 'groupId': 'OG001'}]}]}, {'title': 'Period 1 Day 8 Pre-dose', 'categories': [{'measurements': [{'value': '623.5', 'spread': '381.13', 'groupId': 'OG000'}, {'value': '1155', 'spread': '236.32', 'groupId': 'OG001'}]}]}, {'title': 'Period 1 Day 8 Post-dose', 'categories': [{'measurements': [{'value': '511.0', 'spread': '246.07', 'groupId': 'OG000'}, {'value': '1117', 'spread': '209.29', 'groupId': 'OG001'}]}]}, {'title': 'Period 1 Day 15 Pre-dose', 'categories': [{'measurements': [{'value': '1007', 'spread': '61.518', 'groupId': 'OG000'}, {'value': '843.0', 'spread': '509.31', 'groupId': 'OG001'}]}]}, {'title': 'Period 1 Day 15 Post-dose', 'categories': [{'measurements': [{'value': '797.5', 'spread': '171.83', 'groupId': 'OG000'}, {'value': '736.0', 'spread': '440.86', 'groupId': 'OG001'}]}]}, {'title': 'Period 2 Day 29 Post-dose', 'categories': [{'measurements': [{'value': '122.1', 'spread': '175.93', 'groupId': 'OG000'}, {'value': '137.3', 'spread': '67.458', 'groupId': 'OG001'}]}]}, {'title': 'Period 2 Day 36 Pre-dose', 'categories': [{'measurements': [{'value': '581.2', 'spread': '508.08', 'groupId': 'OG000'}, {'value': '1141', 'spread': '918.53', 'groupId': 'OG001'}]}]}, {'title': 'Period 2 Day 36 Post-dose', 'categories': [{'measurements': [{'value': '550.4', 'spread': '472.91', 'groupId': 'OG000'}, {'value': '1154', 'spread': '787.01', 'groupId': 'OG001'}]}]}, {'title': 'Period 2 Day 43 Pre-dose', 'categories': [{'measurements': [{'value': '137.9', 'spread': '191.11', 'groupId': 'OG000'}, {'value': '1271', 'spread': '847.11', 'groupId': 'OG001'}]}]}, {'title': 'Period 2 Day 43 Post-dose', 'categories': [{'measurements': [{'value': '127.5', 'spread': '177.46', 'groupId': 'OG000'}, {'value': '1181', 'spread': '918.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, only a subset of pharmacokinetic (PK) samples, from 10 out of 190 randomized participants, were selected for analysis. These 10 participants were selected based on treatment and treatment sequence.'}, {'type': 'SECONDARY', 'title': 'Urinary Leukotriene E4 (LTE4) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'OG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'OG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'OG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'timeFrame': 'Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)', 'description': 'LTE4 is a terminal metabolic product of arachidonic acid by 5-LO. Its synthesis is dependent upon the activity of 5-LO and it is eliminated through urinary clearance. Hence, the level of urinary LTE4 (uLTE4) excretion may be an indicator of endogenous 5-LO activity.', 'reportingStatus': 'POSTED', 'populationDescription': 'Since the study was terminated prematurely for a potential safety signal, and in light of the efficacy analysis, the pharmacodynamic (PD) assessment of uLTE4 was not performed and no data are reportable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04191834 Followed by Placebo', 'description': 'PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.'}, {'id': 'FG001', 'title': 'Placebo Followed by PF-04191834', 'description': 'PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.'}, {'id': 'FG002', 'title': 'PF-04191834 + Naproxen Followed by Naproxen', 'description': 'PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.'}, {'id': 'FG003', 'title': 'Naproxen Followed by PF-04191834 + Naproxen', 'description': 'Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '47'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': 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'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes groups randomized to receive PF-04191834 first, placebo first, PF-04191834 plus naproxen first, and naproxen first.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-30', 'studyFirstSubmitDate': '2010-06-16', 'resultsFirstSubmitDate': '2012-12-21', 'studyFirstSubmitQcDate': '2010-06-17', 'lastUpdatePostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-10', 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 1', 'timeFrame': 'Baseline (Day 1 of Visit 3) and end of treatment Period 1 (Day 15+1 of Visit 5)', 'description': 'The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.'}, {'measure': 'Change From Baseline in Western Ontario & McMaster (WOMAC) Osteoarthritis Index Pain Score at the End of Treatment Period 2', 'timeFrame': 'Baseline (Day 28 of Visit 7) and end of treatment Period 2 (Day 43+1 of Visit 9)', 'description': 'The WOMAC Pain subscale, comprised of 5 questions regarding the amount of pain experienced in the index joint, was calculated as the mean of the scores from the 5 individual questions. The WOMAC Pain subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-20, with higher scores indicating higher pain.'}], 'secondaryOutcomes': [{'measure': 'WOMAC Stiffness Domain Score', 'timeFrame': 'Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2', 'description': 'The WOMAC Stiffness subscale, comprised of 2 questions regarding the amount of stiffness experienced in the index joint, was calculated as the mean of the scores from the 2 individual questions. The WOMAC Stiffness subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-8, with higher scores indicating more stiffness.'}, {'measure': 'WOMAC Physical Function Domain Score', 'timeFrame': 'Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2', 'description': "The WOMAC Physical Function subscale refers to the participant's ability to move around and perform usual activities of daily living. The WOMAC Physical Function subscale, comprised of 17 questions regarding the degree of difficulty experienced in the index joint, was calculated as the mean of the scores from the 17 individual questions. The WOMAC Physical Function subscale scores for each question range from 0 to 4 giving a possible overall score range of 0-68, with higher scores indicating worse function."}, {'measure': 'WOMAC Total Score', 'timeFrame': 'Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2', 'description': 'The WOMAC total score was calculated as the sum of Pain subscale score (5 questions), Stiffness subscale score (2 questions) and Physical Function subscale score (17 questions), with a total of 24 questions(score range:0=none, 4=extreme) giving a possible total score range from 0 to 96 . lower subscale scores represent less pain, less stiffness, or better physical performance.'}, {'measure': 'Importance Weighted Total WOMAC Score', 'timeFrame': 'Baseline (Day 1 of Visit 3 for Period 1 and Day 28 of Visit 7 for Period 2), Day 15+1 of Visit 5 for Period 1, and Day 43+1 of Visit 9 for Period 2', 'description': 'Importance weighted total WOMAC score was calculated using all subscales including Pain, Stiffness and Physical Function subscales (24 questions in total,score range: 0=none to 4= extreme,giving a possible overall score range of 0-96).Lower subscale scores represent less pain, less stiffness, or better physical performance.'}, {'measure': 'Daily Diary Pain Score During Week 1 of Each Treatment Period', 'timeFrame': '4 days prior to baseline visits (Visits 3 for Period 1 and Vist 8 for Period 2) up to 7 days after baseline visits', 'description': 'The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).'}, {'measure': 'Daily Diary Pain Score During Week 2 of Each Treatment Period', 'timeFrame': 'Over the last 4 days before baseline visits (Visits 3 for Period 1 and Visit 8 for Period 2) and over the last 6 days before Visit 5 for Period 1 and Visit 9 for Period 2', 'description': 'The daily diary pain was assessed using an 11-point numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain; 10 = the worst pain possible).'}, {'measure': 'Rescue Medication Use', 'timeFrame': 'Day -7 (Visit 2) up to 28-day follow-up (Visit 10)', 'description': 'Rescue medication use was collected daily in a daily diary, in which participants noted the amount of rescue medication (number of pills) taken each day. Participants were provided with rescue medication paracetamol/acetaminophen throughout the study including the Washout Period and the Initial Pain Assessment Period. Paracetamol/acetaminophen was taken as needed to a maximum of 2000 mg per day, but must be discontinued 48 hours prior to the Baseline visit (Visit 3). From Visit 3 onwards, participants might take up to 2000 mg of paracetamol/acetaminophen per day up to 3 days per week.'}, {'measure': 'Plasma Concentration of PF-04191834', 'timeFrame': 'Pre-dose and post-dose (1 to 3 hours) on Days 1, 8, 15, 29, 36, and 43'}, {'measure': 'Urinary Leukotriene E4 (LTE4) Levels', 'timeFrame': 'Day -7 (Visit 2) up to Day 43 (Visit 9 or End of Treatment Period 2)', 'description': 'LTE4 is a terminal metabolic product of arachidonic acid by 5-LO. Its synthesis is dependent upon the activity of 5-LO and it is eliminated through urinary clearance. Hence, the level of urinary LTE4 (uLTE4) excretion may be an indicator of endogenous 5-LO activity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cross-over', 'safety', 'efficacy', 'tolerability', 'osteoarthritis', 'knee', 'pain'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0041007&StudyName=A%20Study%20Of%20The%20Safety%20And%20Efficacy%20Of%20PF-04191834%20In%20Patients%20With%20Osteoarthritis%20Of%20The%20Knee', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'PF-04191834 works in animal models by inhibiting one of the enzymes, 5-lipoxygenasein which is involved in the pathway that causes inflammation and pain. The purpose of this study is to test how effective, safe and tolerated PF-04191834 is in patients with osteoarthritis of the knee by itself or with naproxen, particularly to test if patients have less pain.', 'detailedDescription': "This study has been terminated in response to a reported serious adverse event (SAE). The sponsor's assessment of the limited data available at the time of the initial SAE report was that the SAE may alter the potential benefit - risk profile of the study medication."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must have a diagnosis of osteoarthritis based on the American College of Rheumatology criteria confirmed by an X-ray\n* Subjects must be willing and able to stop all current pain therapy for the duration of the study\n* Subjects must be willing and able to complete a daily diary\n\nExclusion Criteria:\n\n* BMI of \\>39 kg/m2\n* Known allergy or hypersensitivity to naproxen\n* Any condition or medical history that might interfere with the subject's ability to complete the study visits and assessments"}, 'identificationModule': {'nctId': 'NCT01147458', 'briefTitle': 'A Study Of The Safety And Efficacy Of PF-04191834 In Patients With Osteoarthritis Of The Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2 Randomized, Double-Blinded, Double-Dummy, Placebo And Active Controlled Two Cohort Two-Way Cross-Over, Multi-Centre Clinical Trial To Examine The Pain Relief Produced By 2 Weeks Of Daily Oral Administration Of A 5-Lipoxygenase (5-Lox) Inhibitor PF-04191834 Alone And In Combination With Naproxen In Patients With Flare-Enriched Osteoarthritis Of The Knee', 'orgStudyIdInfo': {'id': 'B0041007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04191834 followed by placebo', 'description': 'PF-04191834 600 mg BID dose followed by matched placebo plus naproxen placebo.', 'interventionNames': ['Drug: PF-04191834', 'Drug: PF-04191834 placebo', 'Drug: Naproxen placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo followed by PF-04191834', 'description': 'Placebo followed by 600 mg BID dose of PF-04191834 plus naproxen placebo.', 'interventionNames': ['Drug: PF-04191834 placebo', 'Drug: PF-04191834', 'Drug: Naproxen placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04191834+Naproxen followed by Naproxen', 'description': 'PF-04191834 600 mg BID + Naproxen 500 mg BID followed by Naproxen 500 mg BID plus PF-04191834 placebo', 'interventionNames': ['Drug: PF-04191834', 'Drug: Naproxen', 'Drug: PF-04191834 placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Naproxen followed by PF-04191834+Naproxen', 'description': 'Naproxen 500 mg BID followed by PF-04191834 600 mg BID + Naproxen 500 mg BID', 'interventionNames': ['Drug: Naproxen', 'Drug: PF-04191834 placebo', 'Drug: PF-04191834']}], 'interventions': [{'name': 'PF-04191834', 'type': 'DRUG', 'description': '100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks', 'armGroupLabels': ['PF-04191834 followed by placebo']}, {'name': 'PF-04191834 placebo', 'type': 'DRUG', 'description': 'Matching PF-04191834 placebo tablets to be administered BID for two weeks', 'armGroupLabels': ['PF-04191834 followed by placebo']}, {'name': 'Naproxen placebo', 'type': 'DRUG', 'description': 'Matching naproxen placebo tablets to be administered BID for 4 weeks', 'armGroupLabels': ['PF-04191834 followed by placebo']}, {'name': 'PF-04191834 placebo', 'type': 'DRUG', 'description': 'Matching PF-04191834 placebo tablets to be administered BID for two weeks', 'armGroupLabels': ['Placebo followed by PF-04191834']}, {'name': 'PF-04191834', 'type': 'DRUG', 'description': '100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks', 'armGroupLabels': ['Placebo followed by PF-04191834']}, {'name': 'Naproxen placebo', 'type': 'DRUG', 'description': 'Matching naproxen placebo tablets to be administered BID for 4 weeks', 'armGroupLabels': ['Placebo followed by PF-04191834']}, {'name': 'PF-04191834', 'type': 'DRUG', 'description': '100 mg tablets of PF-04191834 to provide a 600 mg BID dose 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