{ "FullStudy":{ "Rank":218021, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513759", "OrgStudyIdInfo":{ "OrgStudyId":"EKOS 09" }, "Organization":{ "OrgFullName":"EKOS Corporation", "OrgClass":"INDUSTRY" }, "BriefTitle":"Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy", "OfficialTitle":"A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)", "Acronym":"SEATTLE II" }, "StatusModule":{ "StatusVerifiedDate":"July 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 7, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 17, 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 17, 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"June 10, 2019", "ResultsFirstSubmitQCDate":"July 1, 2019", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 5, 2019", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"July 1, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 5, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"EKOS Corporation", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Pulmonary Embolism", "Acute Pulmonary Embolism", "Sub-massive Pulmonary Embolism", "Massive Pulmonary Embolism", "Pulmonary Thromboembolism" ] }, "KeywordList":{ "Keyword":[ "Fibrinolysis", "catheter directed fibrinolysis", "ultrasound accelerated fibrinolysis", "recombinant t-PA", "Activase" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"150", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"EkoSonic® Endovascular System", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: recombinant tissue plasminogen activator", "Device: EKOS EkoSonic Endovascular System" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"recombinant tissue plasminogen activator", "InterventionDescription":"Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "EkoSonic® Endovascular System" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "r-tPA", "t-PA", "Alteplase" ] } },{ "InterventionType":"Device", "InterventionName":"EKOS EkoSonic Endovascular System", "InterventionDescription":"24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "EkoSonic® Endovascular System" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "EkoSonic Endovascular Device", "EkoSonic" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy", "PrimaryOutcomeDescription":"Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.", "PrimaryOutcomeTimeFrame":"Baseline, within 48 +/- 6 hours of initiation of therapy" },{ "PrimaryOutcomeMeasure":"Number of Participants With Major Bleeding", "PrimaryOutcomeDescription":"Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.", "PrimaryOutcomeTimeFrame":"From start of study drug infusion up to 72 hours" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy", "SecondaryOutcomeDescription":"Change in pulmonary artery systolic pressure was assessed by baseline right-heart catheterization compared with right-heart catheterization at the conclusion of ultrasound-accelerated catheter-directed fibrinolysis and estimated by post-procedure transthoracic echocardiography within 48 hours after initiating the procedure.", "SecondaryOutcomeTimeFrame":"Baseline, Hour 48 after initiation of therapy" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)", "SecondaryOutcomeDescription":"Percentage of participants with symptomatic recurrent PE up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported with a Wilson score 95% confidence interval. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.", "SecondaryOutcomeTimeFrame":"Baseline up to Day 30" },{ "SecondaryOutcomeMeasure":"Number of Participants Who Died Due to Any Cause", "SecondaryOutcomeDescription":"Number of participants who died due to any cause for up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported.", "SecondaryOutcomeTimeFrame":"Baseline up to Day 30" },{ "SecondaryOutcomeMeasure":"Number of Devices That Could Not be Successfully Used for Infusion", "SecondaryOutcomeDescription":"Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.", "SecondaryOutcomeTimeFrame":"Baseline up to Day 30" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nComputed tomography (CT) evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery)\nPE symptom duration less than or equal to (<=)14 days\nInformed consent can be obtained from participant or Legally Authorized Representative (LAR)\nMassive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) or\nSubmassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 on contrast-enhanced chest CT)\n\nExclusion Criteria:\n\nStroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year\nRecent (within one month) or active bleeding from a major organ\nHematocrit less than (<) 30 percent (%)\nPlatelets < 100 thousand/microliter (mcL)\nInternational Normalized Ratio (INR) greater than (>) 3\nActivated partial thromboplastin time (aPTT) >50 seconds on no anticoagulants\nMajor surgery within seven days of screening for study enrollment\nSerum creatinine >2 milligrams/deciliter (mg/dL)\nClinician deems high-risk for catastrophic bleeding\nHistory of heparin-induced thrombocytopenia (HIT)\nPregnancy\nCatheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment\nSystolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support\nCardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)\nEvidence of irreversible neurological compromise\nLife expectancy <30 days\nUse of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study\nPrevious enrollment in the SEATTLE study", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Narinder Bhalla, MD", "OverallOfficialAffiliation":"Baptist Health", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"William Kuo, MD", "OverallOfficialAffiliation":"Stanford Hospital and Clinics", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Stephen K Liu, MD", "OverallOfficialAffiliation":"Memorial Medical Center - Modesto", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Immad Sidiq, MD", "OverallOfficialAffiliation":"Hartford Hospital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Samuel Z Goldhaber, MD", "OverallOfficialAffiliation":"Brigham and Women's", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Mark J Garcia, MD", "OverallOfficialAffiliation":"Christiana Hospital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Rohit Bhatheja, MD", "OverallOfficialAffiliation":"AdventHealth", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Robert Kennedy, MD", "OverallOfficialAffiliation":"Holmes Regional Medical Center", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Fakhir Elmasri, MD", "OverallOfficialAffiliation":"Lakeland Regional Medical Center", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Barry S Weinstock, MD", "OverallOfficialAffiliation":"Orlando Regional Medical Center", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Juan Ayerdi, MD", "OverallOfficialAffiliation":"Medical Center of Central Georgia", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Nilesh Goswami, MD", "OverallOfficialAffiliation":"Prairie Heart Institute - St.John's Hospital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Kannan Natarajan, MD", "OverallOfficialAffiliation":"St. Vincent's Hospital-Manhattan", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Tod C Engelhardt, MD", "OverallOfficialAffiliation":"East Jefferson General Hospital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Mark Kumar, MD", "OverallOfficialAffiliation":"Overlook Medical Center", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"John Rundback, MD", "OverallOfficialAffiliation":"Holy Name Hospital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Jacob Cynamon, MD", "OverallOfficialAffiliation":"Montefiore Medical Center", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Peter Soukas, MD", "OverallOfficialAffiliation":"The Miriam Hospital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Mohammad L Raja, MD", "OverallOfficialAffiliation":"Providence Memorial Hospital - Sierra Vista Hospital", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Keith M Sterling, MD", "OverallOfficialAffiliation":"Inova Alexandria", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"John Gurley, MD", "OverallOfficialAffiliation":"University of Kentucky", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Noah Jones, MD", "OverallOfficialAffiliation":"Mt. Carmel East", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Baptist Health", "LocationCity":"Montgomery", "LocationState":"Alabama", "LocationZip":"36116", "LocationCountry":"United States" },{ "LocationFacility":"Memorial Medical Center", "LocationCity":"Modesto", "LocationState":"California", "LocationZip":"95355", "LocationCountry":"United States" },{ "LocationFacility":"Stanford University Medical Center", "LocationCity":"Stanford", "LocationState":"California", "LocationZip":"94305", "LocationCountry":"United States" },{ "LocationFacility":"Hartford Hospital", "LocationCity":"Hartford", "LocationState":"Connecticut", "LocationCountry":"United States" },{ "LocationFacility":"Christiana Hospital", "LocationCity":"Newark", "LocationState":"Delaware", "LocationZip":"19718", "LocationCountry":"United States" },{ "LocationFacility":"Lakeland Regional Medical Center", "LocationCity":"Lakeland", "LocationState":"Florida", "LocationZip":"33805", "LocationCountry":"United States" },{ "LocationFacility":"Holmes Regional Medical Center", "LocationCity":"Melbourne", "LocationState":"Florida", "LocationZip":"32901", "LocationCountry":"United States" },{ "LocationFacility":"Florida Hospital", "LocationCity":"Orlando", "LocationState":"Florida", "LocationZip":"32803", "LocationCountry":"United States" },{ "LocationFacility":"Orlando Regional Medical Center", "LocationCity":"Orlando", "LocationState":"Florida", "LocationZip":"32806", "LocationCountry":"United States" },{ "LocationFacility":"Medical Center of Central Georgia", "LocationCity":"Macon", "LocationState":"Georgia", "LocationZip":"31201", "LocationCountry":"United States" },{ "LocationFacility":"Prairie Heart Institute", "LocationCity":"Springfield", "LocationState":"Illinois", "LocationZip":"62701", "LocationCountry":"United States" },{ "LocationFacility":"St. Vincent Hospital", "LocationCity":"Indianapolis", "LocationState":"Indiana", "LocationCountry":"United States" },{ "LocationFacility":"University of Kentucky, Gill Heart Institute", "LocationCity":"Lexington", "LocationState":"Kentucky", "LocationZip":"40536", "LocationCountry":"United States" },{ "LocationFacility":"East Jefferson General Hospital", "LocationCity":"New Orleans", "LocationState":"Louisiana", "LocationZip":"70006", "LocationCountry":"United States" },{ "LocationFacility":"Hackensack University Medical Center", "LocationCity":"Hackensack", "LocationState":"New Jersey", "LocationZip":"07601", "LocationCountry":"United States" },{ "LocationFacility":"Overlook Medical Center", "LocationCity":"Morristown", "LocationState":"New Jersey", "LocationZip":"07960", "LocationCountry":"United States" },{ "LocationFacility":"Holy Name Hospital", "LocationCity":"Teaneck", "LocationState":"New Jersey", "LocationZip":"07666", "LocationCountry":"United States" },{ "LocationFacility":"Montefiore Medical Center", "LocationCity":"Bronx", "LocationState":"New York", "LocationZip":"10467", "LocationCountry":"United States" },{ "LocationFacility":"Mt. Carmel East", "LocationCity":"Columbus", "LocationState":"Ohio", "LocationZip":"43213", "LocationCountry":"United States" },{ "LocationFacility":"The Miriam Hospital", "LocationCity":"Providence", "LocationState":"Rhode Island", "LocationZip":"02906", "LocationCountry":"United States" },{ "LocationFacility":"Providence Memorial and Sierra Medical Center", "LocationCity":"El Paso", "LocationState":"Texas", "LocationZip":"79902", "LocationCountry":"United States" },{ "LocationFacility":"Inova Alexandria Hospital", "LocationCity":"Alexandria", "LocationState":"Virginia", "LocationZip":"22304", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"27913777", "ReferenceType":"derived", "ReferenceCitation":"Sadiq I, Goldhaber SZ, Liu PY, Piazza G; Submassive and Massive Pulmonary Embolism Treatment with Ultrasound AcceleraTed ThromboLysis ThErapy (SEATTLE II) Investigators. Risk factors for major bleeding in the SEATTLE II trial. Vasc Med. 2017 Feb;22(1):44-50. doi: 10.1177/1358863X16676355. Epub 2017 Jan 31." },{ "ReferencePMID":"26315743", "ReferenceType":"derived", "ReferenceCitation":"Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-92. doi: 10.1016/j.jcin.2015.04.020." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"EkoSonic® Endovascular System", "FlowGroupDescription":"Participants received a total of 24 milligrams (mg) of recombinant tissue plasminogen activator (r-tPA) infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral pulmonary embolism [PE]) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"150" } ] } },{ "FlowMilestoneType":"At Least One Device Successfully Placed", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"149" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"145" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" } ] } },{ "FlowDropWithdrawType":"Death during catheter placement", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"EkoSonic® Endovascular System", "BaselineGroupDescription":"Participants received a total of 24 mg of r-tPA infusion at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"150" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"59.0", "BaselineMeasurementSpread":"16.1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"73" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"77" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Caucasian, Not of Hispanic Origin", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"119" } ] } } ] } },{ "BaselineClassTitle":"African American, Not of Hispanic Origin", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"22" } ] } } ] } },{ "BaselineClassTitle":"Hispanic or Latino", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy", "OutcomeMeasureDescription":"Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.", "OutcomeMeasurePopulationDescription":"Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Overall number of participants analyzed' signifies participants with available data at both baseline and post-baseline. 'Number analyzed' signifies participants with available data at specified timepoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"ratio", "OutcomeMeasureTimeFrame":"Baseline, within 48 +/- 6 hours of initiation of therapy", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EkoSonic® Endovascular System", "OutcomeGroupDescription":"Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"150" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"123" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.55", "OutcomeMeasurementSpread":"0.39" } ] } } ] } },{ "OutcomeClassTitle":"Change within 48 +/- 6 hours", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"115" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.42", "OutcomeMeasurementSpread":"0.36" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Participants With Major Bleeding", "OutcomeMeasureDescription":"Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all participants who started the EkoSonic device placement procedure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"From start of study drug infusion up to 72 hours", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EkoSonic® Endovascular System", "OutcomeGroupDescription":"Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"150" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy", "OutcomeMeasureDescription":"Change in pulmonary artery systolic pressure was assessed by baseline right-heart catheterization compared with right-heart catheterization at the conclusion of ultrasound-accelerated catheter-directed fibrinolysis and estimated by post-procedure transthoracic echocardiography within 48 hours after initiating the procedure.", "OutcomeMeasurePopulationDescription":"Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Number analyzed' signifies participants with available data at specified timepoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"millimeters of mercury (mmHg)", "OutcomeMeasureTimeFrame":"Baseline, Hour 48 after initiation of therapy", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EkoSonic® Endovascular System", "OutcomeGroupDescription":"Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"150" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"150" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"51.4", "OutcomeMeasurementSpread":"16" } ] } } ] } },{ "OutcomeClassTitle":"Change at Hour 48", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"98" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-14.4", "OutcomeMeasurementSpread":"15.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)", "OutcomeMeasureDescription":"Percentage of participants with symptomatic recurrent PE up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported with a Wilson score 95% confidence interval. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.", "OutcomeMeasurePopulationDescription":"Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. One participant was excluded from this analysis due to lost to follow-up after discharge.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Baseline up to Day 30", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EkoSonic® Endovascular System", "OutcomeGroupDescription":"Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"149" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"2.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants Who Died Due to Any Cause", "OutcomeMeasureDescription":"Number of participants who died due to any cause for up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported.", "OutcomeMeasurePopulationDescription":"Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. One participant was excluded from this analysis due to lost to follow-up after discharge.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Baseline up to Day 30", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EkoSonic® Endovascular System", "OutcomeGroupDescription":"Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"149" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Devices That Could Not be Successfully Used for Infusion", "OutcomeMeasureDescription":"Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.", "OutcomeMeasurePopulationDescription":"Safety analysis set included all participants who started the EkoSonic device placement procedure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Units", "OutcomeMeasureUnitOfMeasure":"devices", "OutcomeMeasureTimeFrame":"Baseline up to Day 30", "OutcomeMeasureTypeUnitsAnalyzed":"devices", "OutcomeMeasureDenomUnitsSelected":"devices", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EkoSonic® Endovascular System", "OutcomeGroupDescription":"Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"150" } ] } },{ "OutcomeDenomUnits":"devices", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"285" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"Baseline up to Day 30", "EventsDescription":"Safety analysis set included all participants who started the EkoSonic device placement procedure.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"EkoSonic® Endovascular System", "EventGroupDescription":"Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.", "EventGroupSeriousNumAffected":"28", "EventGroupSeriousNumAtRisk":"150", "EventGroupOtherNumAffected":"59", "EventGroupOtherNumAtRisk":"150" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Anemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Atrial flutter", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Chest Pain", "SeriousEventOrganSystem":"General disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Sepsis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Vascular pseudoaneurysm", "SeriousEventOrganSystem":"Injury, poisoning and procedural complications", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Haematuria", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Acute respiratory failure", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Deep vein thrombosis", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Heparin-induced thrombocytopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Pericardial effusion", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Electroencephalogram abnormal", "SeriousEventOrganSystem":"Investigations", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Renal failure acute", "SeriousEventOrganSystem":"Renal and urinary disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Dyspnoea", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Hypoxia", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Pleural effusion", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Pulmonary arterial hypertension", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Pulmonary embolism", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Respiratory failure", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Haematoma", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Hypotension", "SeriousEventOrganSystem":"Vascular disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Epistaxis", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } },{ "SeriousEventTerm":"Haemorrhagic anaemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 14.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"150" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Anemia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Haemorrhagic anaemia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Heparin-induced thrombocytopenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Leukocytosis", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Thrombocytopenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Atrial fibrillation", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Ventricular arrhythmia", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Abdominal pain", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Abdominal wall haematoma", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Constipation", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Diarrhoea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Gastrointestinal haemorrhage", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Nausea", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Vomiting", "OtherEventOrganSystem":"Gastrointestinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Chest discomfort", "OtherEventOrganSystem":"General disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Chest pain", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Pyrexia", "OtherEventOrganSystem":"Cardiac disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Cellulitis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Pneumonia", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Urinary Tract Infection", "OtherEventOrganSystem":"Infections and infestations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Arterial injury", "OtherEventOrganSystem":"Injury, poisoning and procedural complications", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Contusion", "OtherEventOrganSystem":"Injury, poisoning and procedural complications", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Operative haemorrhage", "OtherEventOrganSystem":"Injury, poisoning and procedural complications", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Wound secretion", "OtherEventOrganSystem":"Injury, poisoning and procedural complications", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Blood creatinine increased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Blood glucose increased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Blood pressure decreased", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Electrocardiogram abnormal", "OtherEventOrganSystem":"Investigations", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Diabetes mellitus", "OtherEventOrganSystem":"Metabolism and nutrition disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Arthralgia", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Facial asymmetry", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Groin pain", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Muscle haemorrhage", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Pain in extremity", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Convulsion", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Haematoma", "OtherEventOrganSystem":"Vascular disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Epistaxis", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Ecchymosis", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Dyspnoea", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Haemoptysis", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Haematuria", "OtherEventOrganSystem":"Renal and urinary disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Deep vein thrombosis", "OtherEventOrganSystem":"Vascular disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Mental status changes", "OtherEventOrganSystem":"Psychiatric disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Rash erythematous", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Renal failure acute", "OtherEventOrganSystem":"Renal and urinary disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Oropharyngeal pain", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Hypertension", "OtherEventOrganSystem":"Vascular disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Hypotension", "OtherEventOrganSystem":"Vascular disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Pleural effusion", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Renal failure chronic", "OtherEventOrganSystem":"Renal and urinary disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"2", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Musculoskeletal stiffness", "OtherEventOrganSystem":"Musculoskeletal and connective tissue disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Pulmonary oedema", "OtherEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } },{ "OtherEventTerm":"Nephrolithiasis", "OtherEventOrganSystem":"Renal and urinary disorders", "OtherEventSourceVocabulary":"MedDRA 14.0", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"150" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"GT60", "AgreementRestrictiveAgreement":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"David Hahn", "PointOfContactOrganization":"EKOS Corporation", "PointOfContactEMail":"David.Hahn@btgplc.com", "PointOfContactPhone":"4254153100" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000010959", "InterventionMeshTerm":"Tissue Plasminogen Activator" },{ "InterventionMeshId":"D000010958", "InterventionMeshTerm":"Plasminogen" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000005343", "InterventionAncestorTerm":"Fibrinolytic Agents" },{ "InterventionAncestorId":"D000050299", "InterventionAncestorTerm":"Fibrin Modulating Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M12432", "InterventionBrowseLeafName":"Tissue Plasminogen Activator", "InterventionBrowseLeafAsFound":"Tissue plasminogen activator", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M12431", "InterventionBrowseLeafName":"Plasminogen", "InterventionBrowseLeafAsFound":"Plasminogen", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M7056", "InterventionBrowseLeafName":"Fibrinolytic Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"FiAg", "InterventionBrowseBranchName":"Fibrinolytic Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000011655", "ConditionMeshTerm":"Pulmonary Embolism" },{ "ConditionMeshId":"D000013923", "ConditionMeshTerm":"Thromboembolism" },{ "ConditionMeshId":"D000004617", "ConditionMeshTerm":"Embolism" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000016769", "ConditionAncestorTerm":"Embolism and Thrombosis" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M13092", "ConditionBrowseLeafName":"Pulmonary Embolism", "ConditionBrowseLeafAsFound":"Pulmonary Embolism", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6367", "ConditionBrowseLeafName":"Embolism", "ConditionBrowseLeafAsFound":"Embolism", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15265", "ConditionBrowseLeafName":"Thromboembolism", "ConditionBrowseLeafAsFound":"Thromboembolism", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15269", "ConditionBrowseLeafName":"Thrombosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17711", "ConditionBrowseLeafName":"Embolism and Thrombosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }