Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT00141102
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2005-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland', 'Serbia and Montenegro']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'D004008', 'term': 'Diclofenac'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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}}, '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': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo', 'otherNumAtRisk': 2223, 'otherNumAffected': 530, 'seriousNumAtRisk': 2223, 'seriousNumAffected': 61}, {'id': 'EG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.', 'otherNumAtRisk': 2237, 'otherNumAffected': 669, 'seriousNumAtRisk': 2237, 'seriousNumAffected': 61}], 'otherEvents': [{'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 133}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 168}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 137}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 111}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 66}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 67}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 72}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 84}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'seriousEvents': [{'term': 'Normochromic normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Erosive oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Burn infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pyothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Comminuted fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Eye burns', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Forearm fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Gun 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'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypoaesthesia facial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Carpal tunnel decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Open reduction of fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Prolapse repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Rectocele repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}, {'term': 'Thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2237, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2238', 'groupId': 'OG000'}, {'value': '2246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '4.32', 'statisticalMethod': 'Life Table Extension', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by history of GD ulceration and by region.'}], 'paramType': 'NUMBER', 'timeFrame': '6 month treatment duration', 'description': 'CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2238', 'groupId': 'OG000'}, {'value': '2246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.93', 'statisticalMethod': 'Life Table Extension', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by history of GD ulceration and by region.'}], 'paramType': 'NUMBER', 'timeFrame': '6 month treatment duration', 'description': 'CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. n = number of subjects with CSULGIEs or SUs as confirmed by the committee.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '2207', 'groupId': 'OG000'}, {'value': '2213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.754', 'spread': '0.020', 'groupId': 'OG000'}, {'value': '0.773', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4146', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.019', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.023', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed effects of region and history of GD ulceration with Baseline covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 6/Early Termination (ET)', 'description': 'Subjects rated response to question: "Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?" using a 1 to 5 grading scale where 1=very good and 5=very poor.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. Number of Participants Analyzed = number of subjects with data available for the analysis. Last Observation Carried Forward (LOCF) method was used.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With SUs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2238', 'groupId': 'OG000'}, {'value': '2246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1132', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.29', 'statisticalMethod': 'Life Table Extension', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by history of GD ulceration and by region.'}], 'paramType': 'NUMBER', 'timeFrame': '6 month treatment duration', 'description': 'Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With CSULGIEs by History of GD Ulceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2238', 'groupId': 'OG000'}, {'value': '2246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'title': 'History of GD Ulceration (n=395, 400)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'No History of GD Ulceration (n=1843, 1846)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 month treatment duration', 'description': 'CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. n = number of subjects who had history or no history of GD ulceration.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Moderate to Severe Abdominal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2238', 'groupId': 'OG000'}, {'value': '2246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0495', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.26', 'statisticalMethod': 'Life Table Extension', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by history of GD ulceration and by region.'}], 'paramType': 'NUMBER', 'timeFrame': '6 month treatment duration', 'description': 'Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) \'Gastrointestinal Disorders\' and keeping high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Withdrawn Due to GI Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2238', 'groupId': 'OG000'}, {'value': '2246', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '114', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.52', 'statisticalMethod': 'Life Table Extension', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by history of GD ulceration and by region.'}], 'paramType': 'NUMBER', 'timeFrame': '6 month treatment duration', 'description': 'GI AEs were defined using MedDRA SOC "Gastrointestinal Disorders" but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin at Month 6/ET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2184', 'groupId': 'OG000'}, {'value': '2167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.017', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '-0.423', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.406', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.45', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.022', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed effects of region and history of GD ulceration with Baseline covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 6/ET', 'unitOfMeasure': 'grams (g)/deciliter (dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population = all randomized subjects who received at least 1 dose of study medication. Number of Participants Analyzed = number of subjects with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrit at Month 6/ET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2184', 'groupId': 'OG000'}, {'value': '2167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.306', 'spread': '0.059', 'groupId': 'OG000'}, {'value': '-1.425', 'spread': '0.059', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.118', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.069', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed effects of region and history of GD ulceration with Baseline covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 6/ET', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of Participants Analyzed = number of subjects with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2184', 'groupId': 'OG000'}, {'value': '2167', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.748', 'ciLowerLimit': '1.96', 'ciUpperLimit': '3.84', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Stratified by history of GD ulceration and by region.'}], 'paramType': 'NUMBER', 'timeFrame': '6 month treatment duration', 'description': 'A clinically significant decrease from baseline was defined as a fall in hematocrit \\> = 10 percentage points and/or hemoglobin \\> = 2 g/dL.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of Participants Analyzed = number of subjects with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2223', 'groupId': 'OG000'}, {'value': '2237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.'}], 'classes': [{'title': 'GGT', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'ALT', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.329', 'ciLowerLimit': '2.156', 'ciUpperLimit': '5.141', 'groupDescription': 'GGT', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3809', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.509', 'ciLowerLimit': '0.618', 'ciUpperLimit': '3.684', 'groupDescription': 'AST', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0264', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative Risk', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.089', 'ciLowerLimit': '1.081', 'ciUpperLimit': '4.038', 'groupDescription': 'ALT', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '6 month treatment duration', 'description': 'GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of participants analyzed = number of subjects with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2223', 'groupId': 'OG000'}, {'value': '2237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'title': 'GGT', 'categories': [{'measurements': [{'value': '-2.689', 'spread': '0.591', 'groupId': 'OG000'}, {'value': '7.455', 'spread': '0.592', 'groupId': 'OG001'}]}]}, {'title': 'AST', 'categories': [{'measurements': [{'value': '-0.901', 'spread': '0.239', 'groupId': 'OG000'}, {'value': '1.490', 'spread': '0.239', 'groupId': 'OG001'}]}]}, {'title': 'ALT', 'categories': [{'measurements': [{'value': '-1.151', 'spread': '0.364', 'groupId': 'OG000'}, {'value': '5.213', 'spread': '0.364', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.144', 'ciLowerLimit': '-11.51', 'ciUpperLimit': '-8.78', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.697', 'groupDescription': 'GGT', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.391', 'ciLowerLimit': '-2.94', 'ciUpperLimit': '-1.84', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.281', 'groupDescription': 'AST', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.364', 'ciLowerLimit': '-7.20', 'ciUpperLimit': '-5.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.428', 'groupDescription': 'ALT', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 6/ET', 'unitOfMeasure': 'IU/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of participants analyzed = number of subjects with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Iron Binding Capacity to Month 6/ET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2185', 'groupId': 'OG000'}, {'value': '2171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.517', 'spread': '1.158', 'groupId': 'OG000'}, {'value': '1.952', 'spread': '1.161', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6795', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.565', 'ciLowerLimit': '-2.11', 'ciUpperLimit': '3.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.366', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed effects of region and history of GD ulceration with Baseline covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 6/ET', 'unitOfMeasure': 'microgram (ug)/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of participants analyzed = number of subjects with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Ferretin to Month 6/ET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2185', 'groupId': 'OG000'}, {'value': '2170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.396', 'spread': '2.224', 'groupId': 'OG000'}, {'value': '-1.990', 'spread': '2.228', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5920', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.406', 'ciLowerLimit': '-6.55', 'ciUpperLimit': '3.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.624', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed effects of region and history of GD ulceration with Baseline covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 6/ET', 'unitOfMeasure': 'ug/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of participants analyzed = number of subjects with analyzable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein to Month 6/ET', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2185', 'groupId': 'OG000'}, {'value': '2171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.058', 'spread': '0.032', 'groupId': 'OG000'}, {'value': '0.073', 'spread': '0.032', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6819', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.015', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.038', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Fixed effects of region and history of GD ulceration with Baseline covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Month 6/ET', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of participants analyzed = number of subjects with analyzable data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects Alive at the Post Trial Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2047', 'groupId': 'OG000'}, {'value': '2048', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '2018', 'groupId': 'OG000'}, {'value': '2023', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months following last dose', 'description': 'Interview occurred via telephone to obtain follow-up mortality and hospitalization information.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of participants analyzed = number of subjects with follow-up information available.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2047', 'groupId': 'OG000'}, {'value': '2048', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'OG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months following last dose', 'description': 'Interview occurred via telephone to obtain follow-up mortality and hospitalization information.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Number of participants analyzed = number of subjects with follow-up information available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Celecoxib', 'description': '200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo'}, {'id': 'FG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily \\[QD\\]) and celecoxib placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2238'}, {'groupId': 'FG001', 'numSubjects': '2246'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2223'}, {'groupId': 'FG001', 'numSubjects': '2237'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1730'}, {'groupId': 'FG001', 'numSubjects': '1621'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '508'}, {'groupId': 'FG001', 'numSubjects': '625'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '305'}]}, {'type': 'Laboratory Abnormality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '142'}]}, {'type': 'Randomized But Did Not Receive Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2238', 'groupId': 'BG000'}, {'value': '2246', 'groupId': 'BG001'}, {'value': '4484', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Celecoxib', 'description': '200 mg BID plus omeprazole placebo and diclofenac SR placebo'}, {'id': 'BG001', 'title': 'Oral Diclofenac Plus Omeprazole', 'description': 'Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 55 years', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '164', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}]}, {'title': '55 to 59 years', 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '235', 'groupId': 'BG002'}]}]}, {'title': '60 to 64 years', 'categories': [{'measurements': [{'value': '721', 'groupId': 'BG000'}, {'value': '742', 'groupId': 'BG001'}, {'value': '1463', 'groupId': 'BG002'}]}]}, {'title': '65 to 69 years', 'categories': [{'measurements': [{'value': '623', 'groupId': 'BG000'}, {'value': '618', 'groupId': 'BG001'}, {'value': '1241', 'groupId': 'BG002'}]}]}, {'title': '70 to 74 years', 'categories': [{'measurements': [{'value': '361', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '751', 'groupId': 'BG002'}]}]}, {'title': '> = 75 years', 'categories': [{'measurements': [{'value': '235', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '454', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1848', 'groupId': 'BG000'}, {'value': '1822', 'groupId': 'BG001'}, {'value': '3670', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '390', 'groupId': 'BG000'}, {'value': '424', 'groupId': 'BG001'}, {'value': '814', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4484}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-01', 'studyFirstSubmitDate': '2005-08-29', 'resultsFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-05-11', 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Subjects Alive at the Post Trial Interview', 'timeFrame': '6 months following last dose', 'description': 'Interview occurred via telephone to obtain follow-up mortality and hospitalization information.'}, {'measure': 'Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview', 'timeFrame': '6 months following last dose', 'description': 'Interview occurred via telephone to obtain follow-up mortality and hospitalization information.'}], 'primaryOutcomes': [{'measure': 'Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)', 'timeFrame': '6 month treatment duration', 'description': 'CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)', 'timeFrame': '6 month treatment duration', 'description': 'CSULGIE=any of the following: GD hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.'}, {'measure': "Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)", 'timeFrame': 'Month 6/Early Termination (ET)', 'description': 'Subjects rated response to question: "Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?" using a 1 to 5 grading scale where 1=very good and 5=very poor.'}, {'measure': 'Number of Subjects With SUs', 'timeFrame': '6 month treatment duration', 'description': 'Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.'}, {'measure': 'Number of Subjects With CSULGIEs by History of GD Ulceration', 'timeFrame': '6 month treatment duration', 'description': 'CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.'}, {'measure': 'Number of Subjects With Moderate to Severe Abdominal Symptoms', 'timeFrame': '6 month treatment duration', 'description': 'Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) \'Gastrointestinal Disorders\' and keeping high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms".'}, {'measure': 'Number of Subjects Withdrawn Due to GI Adverse Events (AEs)', 'timeFrame': '6 month treatment duration', 'description': 'GI AEs were defined using MedDRA SOC "Gastrointestinal Disorders" but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.'}, {'measure': 'Change From Baseline in Hemoglobin at Month 6/ET', 'timeFrame': 'Month 6/ET'}, {'measure': 'Change From Baseline in Hematocrit at Month 6/ET', 'timeFrame': 'Month 6/ET'}, {'measure': 'Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin', 'timeFrame': '6 month treatment duration', 'description': 'A clinically significant decrease from baseline was defined as a fall in hematocrit \\> = 10 percentage points and/or hemoglobin \\> = 2 g/dL.'}, {'measure': 'Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)', 'timeFrame': '6 month treatment duration', 'description': 'GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.'}, {'measure': 'Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET', 'timeFrame': 'Month 6/ET'}, {'measure': 'Change From Baseline in Iron Binding Capacity to Month 6/ET', 'timeFrame': 'Month 6/ET'}, {'measure': 'Change From Baseline in Ferretin to Month 6/ET', 'timeFrame': 'Month 6/ET'}, {'measure': 'Change From Baseline in C-Reactive Protein to Month 6/ET', 'timeFrame': 'Month 6/ET'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GI events in high risk GI arthritis patients'], 'conditions': ['Osteoarthritis', 'Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '24358067', 'type': 'DERIVED', 'citation': 'Kellner HL, Li C, Essex MN. Celecoxib and Diclofenac Plus Omeprazole are Similarly Effective in the Treatment of Arthritis in Patients at High GI Risk in the CONDOR Trial. Open Rheumatol J. 2013 Nov 13;7:96-100. doi: 10.2174/1874312901307010096. eCollection 2013.'}, {'pmid': '20638563', 'type': 'DERIVED', 'citation': 'Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet. 2010 Jul 17;376(9736):173-9. doi: 10.1016/S0140-6736(10)60673-3. Epub 2010 Jun 16.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191084&StudyName=Study%20Of%20Celecoxib%20Or%20Diclofenac%20And%20Omeprazole%20For%20Gastrointestinal%20%28GI%29%20Safety%20In%20High%20GI%20Risk%20Patients%20With%20Arthritis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a clinical diagnosis of OA or RA and who are expected to require regular anti-inflammatory therapy for arthritis symptom management\n* Subjects must be aged 60 years or older with or without a history of gastroduodenal (GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit\n\nExclusion Criteria:\n\n* Active GD ulceration or GD ulceration within 90 days of the screening visit.\n* Concomitant use of low dose aspirin\n* Previous MI, stroke or significant vascular disease.'}, 'identificationModule': {'nctId': 'NCT00141102', 'acronym': 'CONDOR', 'briefTitle': 'Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of 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