{ "FullStudy":{ "Rank":218161, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01511939", "OrgStudyIdInfo":{ "OrgStudyId":"ATCCTCP-1" }, "Organization":{ "OrgFullName":"Arthritis Treatment Center, Maryland", "OrgClass":"OTHER" }, "BriefTitle":"Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants", "OfficialTitle":"Single Center, Open-label Study of Effect of PENNSAID (Diclofenac Sodium Solution Topical) on Coagulation Parameters (PT, PTT, INR and Platelet Function) in Patients With Moderate to Severe Osteoarthritis Pain of the Knee Taking Anticoagulant Medication", "Acronym":"ATCCTCP-1" }, "StatusModule":{ "StatusVerifiedDate":"June 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 9, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 26, 2014", "ResultsFirstSubmitQCDate":"June 24, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 26, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 24, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 26, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Nathan Wei, MD, FACP, FACR:", "ResponsiblePartyInvestigatorTitle":"Nathan Wei, MD, FACP, FACR", "ResponsiblePartyInvestigatorAffiliation":"Arthritis Treatment Center, Maryland" }, "LeadSponsor":{ "LeadSponsorName":"Nathan Wei, MD, FACP, FACR:", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Medtronic - MITG", "CollaboratorClass":"INDUSTRY" },{ "CollaboratorName":"Arthritis Treatment Center, Maryland", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who are also taking anticoagulant or antithrombotic medications.", "DetailedDescription":"Open-label active treatment Phase III study of Pennsaid (diclofenac sodium 1.5% topical solution) to determine the effects on coagulation parameters in patients who are equal to or greater than 55 years of age with moderate to severe osteoarthritis knee pain and who are also taking warfarin, dabigatran, or aspirin and/or clopidogrel." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Osteoarthritis of the Knee", "Coagulopathy" ] }, "KeywordList":{ "Keyword":[ "Knee pain", "Anticoagulant", "Warfarin", "Dabigatran", "Clopidogrel", "Aspirin", "Topical NSAID", "Osteoarthritis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"22", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Pennsaid, warfarin", "ArmGroupType":"Other", "ArmGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Pennsaid" ] } },{ "ArmGroupLabel":"Pennsaid, dabigatran", "ArmGroupType":"Other", "ArmGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Pennsaid" ] } },{ "ArmGroupLabel":"Pennsaid, aspirin and/or clopidogrel", "ArmGroupType":"Other", "ArmGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Pennsaid" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Pennsaid", "InterventionDescription":"Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Pennsaid, aspirin and/or clopidogrel", "Pennsaid, dabigatran", "Pennsaid, warfarin" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Pennsaid 1.5%", "Diclofenac sodium 1.5% topical solution", "Topical nonsteroidal antiinflammatory drug", "Topical NSAID" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)", "PrimaryOutcomeDescription":"PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.", "PrimaryOutcomeTimeFrame":"Baseline to week 4" },{ "PrimaryOutcomeMeasure":"Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)", "PrimaryOutcomeDescription":"INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.", "PrimaryOutcomeTimeFrame":"Baseline to Week 4" },{ "PrimaryOutcomeMeasure":"Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)", "PrimaryOutcomeDescription":"PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.", "PrimaryOutcomeTimeFrame":"Baseline to Week 4" },{ "PrimaryOutcomeMeasure":"Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation", "PrimaryOutcomeDescription":"Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.", "PrimaryOutcomeTimeFrame":"Baseline to Week 4" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or female adults > than or equal to 55\nAmbulatory subjects with moderate to severe osteoarthritis (OA) of the knee with symptoms and knee pain for at least 3 months and pain on the majority of days in the last 30 days.\nSubjects with bilateral knee OA, the more symptomatic knee is the index knee and PENNSAID can be applied on both knees if both are affected.\nRadiographic evidence of Kellgren-Lawrence Grade 2-4 within the past 2 years.\nCurrently on a stable dose of anticoagulant therapy (warfarin, dabigatran, aspirin or clopidogrel) for the past 2 months and expected to remain on current dose for the six week duration of the study.\nIf currently taking oral nonsteroidal antiinflammatory drug (NSAID) and/or acetaminophen for OA knee pain, must be taking it for at least an average of 25 days per month.\nThose currently taking oral NSAID must be willing to perform a 7 day washout to be eligible to be enrolled into the study.\nA pain score of > than 40mm on the Patient Pain Visual Analog Scale (VAS) (100 mm scale) at screening and baseline visit.\nAble to comply with the study and give informed consent prior to performance of any study procedures.\nAble to read, write and understand English.\n\nExclusion Criteria:\n\nUnwilling to abstain from oral NSAIDs and/or other analgesic medication except for acetaminophen as rescue medication. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.\nUnwilling to abstain from taking < than or equal to 1500mg of acetaminophen a day for rescue medication purposes during the 6 week course of the trial.\nUsing a handicap assistance device i.e. cane, walker > than or equal to 50% of the time.\nUndergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening and won't remain stable during participation in study.\nHistory or diagnosis of an inflammatory arthritis i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.\nKnown or clinically suspected infection and human immunodeficiency virus (HIV), or hepatitis C or B viruses.\nHistory of abnormal laboratory results > that or equal to 2.5 x upper limit of normal (ULN) indicative of any significant medical disease which in the opinion of the investigator, would preclude the subjects participation in the study.\nAny of the following abnormal laboratory results during screening:\nAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) > than or equal to 2.5 x ULN\nHemoglobin < than 11.5 g/dL (female) or < 13.2 g/dL (male)\nWhite blood cell count (WBC) < than 3500 cells/mm3\nLymphocyte count < than or equal to 1000 cels/mm3\nSerum creatinine > than or equal 1.5 x ULN\nPlatelet count below the central laboratory lower limit of normal (LLN)\nCoagulation tests (Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR), Platelet Aggregation) requiring an alteration in anticoagulant dosage.\nSkin breakdown or rash at knee where topical PENNSAID is to be applied.\nOther serious uncontrolled non-malignant, significant, acute or chronic medical or psychiatric illness that, in judgment of investigator, could compromise subject safety, limit subject's ability to complete study and/or compromise the objectives of study.\nHistory of malignancy in the past 5 years with exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.\nHistory of drug or alcohol dependence or abuse in the past 3 years.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"55 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Nathan Wei, MD,FACP,FACR", "OverallOfficialAffiliation":"Arthritis Treatment Center, Frederick, Maryland, United States, 21702", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Arthritis Treatment Center", "LocationCity":"Frederick", "LocationState":"Maryland", "LocationZip":"21702", "LocationCountry":"United States" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Pennsaid, Warfarin", "FlowGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis (OA) pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Pennsaid, Dabigatran", "FlowGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Pennsaid, Aspirin and/or Clopidogrel", "FlowGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"Includes 1 subject who was also taking aspirin.", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementComment":"Includes one patient who was also taking aspirin.", "FlowAchievementNumSubjects":"5" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"8" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"8" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"2" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"One subject in the warfarin group and one subject in the dabigatran group were also taking aspirin. For the Outcome measures, these two subjects were also included in the aspirin and/or clopidogrel group.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Pennsaid, Warfarin", "BaselineGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Pennsaid, Dabigatran", "BaselineGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Pennsaid, Aspirin and/or Clopidogrel", "BaselineGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"9" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"5" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"8" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"22" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Customized", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"> / = 55 years", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"22" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"15" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"7" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"22" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)", "OutcomeMeasureDescription":"PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.", "OutcomeMeasurePopulationDescription":"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the \"Pennsaid, warfarin\" group, and the subject who was taking dabigatran and aspirin was included only in the \"Pennsaid, dabigatran\" group.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"seconds", "OutcomeMeasureTimeFrame":"Baseline to week 4", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pennsaid, Warfarin", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Pennsaid, Dabigatran", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pennsaid, Aspirin and/or Clopidogrel", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.97", "OutcomeMeasurementLowerLimit":"0.20", "OutcomeMeasurementUpperLimit":"10.80" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.96", "OutcomeMeasurementLowerLimit":"-2.40", "OutcomeMeasurementUpperLimit":"2.30" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.04", "OutcomeMeasurementLowerLimit":"-0.80", "OutcomeMeasurementUpperLimit":"0.70" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)", "OutcomeMeasureDescription":"INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.", "OutcomeMeasurePopulationDescription":"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the \"Pennsaid, warfarin\" group, and the subject who was taking dabigatran and aspirin was included only in the \"Pennsaid, dabigatran\" group.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"ratio", "OutcomeMeasureTimeFrame":"Baseline to Week 4", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pennsaid, Warfarin", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Pennsaid, Dabigatran", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pennsaid, Aspirin and/or Clopidogrel", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.63", "OutcomeMeasurementLowerLimit":"0.01", "OutcomeMeasurementUpperLimit":"1.00" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.09", "OutcomeMeasurementLowerLimit":"-0.21", "OutcomeMeasurementUpperLimit":"0.20" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.00", "OutcomeMeasurementLowerLimit":"-0.07", "OutcomeMeasurementUpperLimit":"0.07" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)", "OutcomeMeasureDescription":"PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.", "OutcomeMeasurePopulationDescription":"Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the \"Pennsaid, warfarin\" group, and the subject who was taking dabigatran and aspirin was included only in the \"Pennsaid, dabigatran\" group.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"Seconds", "OutcomeMeasureTimeFrame":"Baseline to Week 4", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pennsaid, Warfarin", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Pennsaid, Dabigatran", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pennsaid, Aspirin and/or Clopidogrel", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"8" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.68", "OutcomeMeasurementLowerLimit":"-1.20", "OutcomeMeasurementUpperLimit":"6.30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.50", "OutcomeMeasurementLowerLimit":"-5.80", "OutcomeMeasurementUpperLimit":"7.20" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-0.29", "OutcomeMeasurementLowerLimit":"-2.90", "OutcomeMeasurementUpperLimit":"2.30" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation", "OutcomeMeasureDescription":"Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.", "OutcomeMeasurePopulationDescription":"For this analysis, the subject who was taking warfarin and aspirin was included in both the \"Pennsaid, warfarin\" group and the \"Pennsaid, aspirin and/or clopidogrel\" group, and the subject who was taking dabigatran and aspirin was included in both the \"Pennsaid, dabigatran\" group and the \"Pennsaid, aspirin and/or clopidogrel\" group.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"Seconds", "OutcomeMeasureTimeFrame":"Baseline to Week 4", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Pennsaid, Warfarin", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Pennsaid, Dabigatran", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Pennsaid, Aspirin and/or Clopidogrel", "OutcomeGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"7" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"4" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"10" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8.14", "OutcomeMeasurementLowerLimit":"-16.00", "OutcomeMeasurementUpperLimit":"43.00" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-39.25", "OutcomeMeasurementLowerLimit":"-110.00", "OutcomeMeasurementUpperLimit":"-4.00" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"-13.30", "OutcomeMeasurementLowerLimit":"-155.00", "OutcomeMeasurementUpperLimit":"117.00" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Pennsaid, Warfarin", "EventGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"9", "EventGroupOtherNumAffected":"6", "EventGroupOtherNumAtRisk":"9" },{ "EventGroupId":"EG001", "EventGroupTitle":"Pennsaid, Dabigatran", "EventGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"5", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"5" },{ "EventGroupId":"EG002", "EventGroupTitle":"Pennsaid, Aspirin and/or Clopidogrel", "EventGroupDescription":"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months\n\nPennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"10", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"10" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Epistaxis", "SeriousEventOrganSystem":"General disorders", "SeriousEventNotes":"Epistaxis resulting in hospitalization and blood transfusion; assessed by Principal Investigator as not related to Pennsaid because patient had a history of sinus surgery which has resulted in a history of occasional severe epistaxis.", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"9" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"5" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"10" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Bowel Impaction", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventNotes":"Assessed by Principal Investigator as not related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Swelling of lower extremities", "OtherEventOrganSystem":"Vascular disorders", "OtherEventNotes":"Assessed by Principal Investigator as possibly related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Epistaxis", "OtherEventOrganSystem":"General disorders", "OtherEventNotes":"Assessed by Principal Investigator as not related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Broken Tooth", "OtherEventOrganSystem":"General disorders", "OtherEventNotes":"Assessed by Principal Investigator as not related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventNotes":"Assessed by Principal Investigator as possibly related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Shortness of breath", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventNotes":"Assessed by Principal Investigator as not likely related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Rash on lower extremities", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventNotes":"Assessed by Principal Investigator as possibly related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Influenza", "OtherEventOrganSystem":"Infections and infestations", "OtherEventNotes":"Assessed by Principal Investigator as not related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"2", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Gastroenteritis", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventNotes":"Assessed by Principal Investigator as not related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventNotes":"Assessed by Principal Investigator as not related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Metallic taste in mouth", "OtherEventOrganSystem":"General disorders", "OtherEventNotes":"Assessed by Principal Investigator as possibly related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Headache", "OtherEventOrganSystem":"General disorders", "OtherEventNotes":"Assessed by Principal Investigator as possibly related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Hyperglycemia", "OtherEventOrganSystem":"Endocrine disorders", "OtherEventNotes":"Assessed by Principal Investigator as not likely related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" } ] } },{ "OtherEventTerm":"Pneumonia", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventNotes":"Assessed by Principal Investigator as not related to Pennsaid", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"9" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"5" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"10" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Manager, Clinical Research Department", "PointOfContactOrganization":"Arthritis Treatment Center", "PointOfContactEMail":"tgillis@arthritistreatmentcenter.com", "PointOfContactPhone":"301-624-1168" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000004008", "InterventionMeshTerm":"Diclofenac" },{ "InterventionMeshId":"D000000894", "InterventionMeshTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionMeshId":"D000000893", "InterventionMeshTerm":"Anti-Inflammatory Agents" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" },{ "InterventionAncestorId":"D000016861", "InterventionAncestorTerm":"Cyclooxygenase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M20444", "InterventionBrowseLeafName":"Pharmaceutical Solutions", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5780", 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"ConditionBrowseLeafName":"Arthritis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9204", "ConditionBrowseLeafName":"Joint Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10680", "ConditionBrowseLeafName":"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13628", "ConditionBrowseLeafName":"Rheumatic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4906", "ConditionBrowseLeafName":"Collagen Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC05", "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" } ] } } } } } }