{ "FullStudy":{ "Rank":217568, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519700", "OrgStudyIdInfo":{ "OrgStudyId":"EP06-302" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2010-024481-22", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Sandoz", "OrgClass":"INDUSTRY" }, "BriefTitle":"Phase III Study Comparing the Efficacy and Safety of EP2006 and Filgrastim", "OfficialTitle":"A Randomized, Double-blind, Parallel-group, Multi-center Phase III Study Comparing the Efficacy and Safety of EP2006 and Neupogen® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy", "Acronym":"PIONEER" }, "StatusModule":{ "StatusVerifiedDate":"April 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 25, 2015", "ResultsFirstSubmitQCDate":"March 25, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 7, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 14, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 6, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Sandoz", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chemotherapy Associated Neutropenia", "Breast Cancer" ] }, "KeywordList":{ "Keyword":[ "Filgrastim", "G-CSF, neutropenia", "supportive care", "breast cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Supportive Care", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"218", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"EP2006", "ArmGroupType":"Experimental", "ArmGroupDescription":"Eligible patients will be teated with EP2006", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: EP2006" ] } },{ "ArmGroupLabel":"Filgrastim", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Eligible patients will be teated with Filgrastim", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Filgrastim" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"EP2006", "InterventionDescription":"Eligible patients will be teated with EP2006", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "EP2006" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Filgrastim" ] } },{ "InterventionType":"Drug", "InterventionName":"Filgrastim", "InterventionDescription":"Eligible patients will be teated with Filgrastim", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Filgrastim" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy", "PrimaryOutcomeDescription":"Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)", "PrimaryOutcomeTimeFrame":"21 days (Cycle 1 of chemotherapy treatment)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Incidence of Febrile Neutropenia", "SecondaryOutcomeDescription":"Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)", "SecondaryOutcomeTimeFrame":"21 weeks/ 6 cycles" },{ "SecondaryOutcomeMeasure":"Number of Days of Fever", "SecondaryOutcomeDescription":"Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.", "SecondaryOutcomeTimeFrame":"21 weeks/ 6 cycles" },{ "SecondaryOutcomeMeasure":"Depth of Absolute Neutrophil Count Nadir", "SecondaryOutcomeDescription":"Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1", "SecondaryOutcomeTimeFrame":"Cycle 1/ 21 days" },{ "SecondaryOutcomeMeasure":"Time to Absolute Neutrophil Count Recovery", "SecondaryOutcomeDescription":"Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1", "SecondaryOutcomeTimeFrame":"Cycle 1/ 21 days" },{ "SecondaryOutcomeMeasure":"Frequency of Infections", "SecondaryOutcomeDescription":"Frequency of infections by cycle and across all cycles", "SecondaryOutcomeTimeFrame":"21 Weeks/ 6 cycles" },{ "SecondaryOutcomeMeasure":"Incidence of Hospitalizations Due to Febrile Neutropenia", "SecondaryOutcomeDescription":"Incidence of hospitalizations due to Febrile Neutropenia", "SecondaryOutcomeTimeFrame":"21 Weeks/ 6 cycles" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy\nWomen ≥ 18 years of age\nEstimated life expectancy of more than six months\n\nExclusion Criteria:\n\nPrevious or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry\nAny serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:\n\nOther protocol-defined inclusion/exclusion criteria may apply.", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Sandoz", "OverallOfficialAffiliation":"Sandoz", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Insitut Onkologie a Rehabilitaca na Plesi", "LocationCity":"Ves pod Plesi 110", "LocationZip":"26204", "LocationCountry":"Czech Republic" },{ "LocationFacility":"Semmelweis Egyetem, III. Belgyogyaszati Klinika", "LocationCity":"Budapest", "LocationZip":"1125", "LocationCountry":"Hungary" },{ "LocationFacility":"Fovarosi Onkormanyzat Uzsoki utcai Korhaz, Onkoradiologia", "LocationCity":"Budapest", "LocationZip":"1145", "LocationCountry":"Hungary" },{ "LocationFacility":"DE OEC, Onkologiai Tanszek", "LocationCity":"Debrecen", "LocationZip":"4032", "LocationCountry":"Hungary" },{ "LocationFacility":"Josa Andras Oktato Korhaz Nonprofit Kft", "LocationCity":"Nyiregyhaza", "LocationZip":"4400", "LocationCountry":"Hungary" },{ "LocationFacility":"Fejer Megyei Szent Gyorgy Korhaz, Onkologiai Osztaly", "LocationCity":"Szekesfehervar", "LocationZip":"8000", "LocationCountry":"Hungary" },{ "LocationFacility":"Vas Megyei Markusovszky Korhaz, Onkoradiologiai Osztaly", "LocationCity":"Szombathely", "LocationZip":"9700", "LocationCountry":"Hungary" },{ "LocationFacility":"Daugavpils Regional Hospital", "LocationCity":"Daugavpils", "LocationZip":"5400", "LocationCountry":"Latvia" },{ "LocationFacility":"Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS", "LocationCity":"Moscow", "LocationState":"Krasnogorsk district", "LocationZip":"143423", "LocationCountry":"Russian Federation" },{ "LocationFacility":"State Healthcare Institution (SHI) \"Leningrad Regional Oncological Dispensary\" at the Surgery Department 2", "LocationCity":"Kuzmolovsky", "LocationState":"Leningrad region", "LocationZip":"188663", "LocationCountry":"Russian Federation" },{ "LocationFacility":"State Medical-Prophylactic Institution SMPI Reginal Clinical Oncological Dispensary", "LocationCity":"Chelyabinsk", "LocationZip":"454087", "LocationCountry":"Russian Federation" },{ "LocationFacility":"State Healthcare Institution (SHI) \"Clinical Oncological Dispensary №1\" of Healthcare Department of Krasnodar Territory", "LocationCity":"Krasnodar", "LocationZip":"350040", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Institution of the Russian Academy of Medical Sciences Russian Oncology Research Center n.a. N.N.Blochin of RAMS\", Surgery Department of the Female Reproductive System Tumors", "LocationCity":"Moscow", "LocationZip":"115478", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Affiliate No1 of State Healthcare Institution (SHI) \"Nizhny Novgorod Regional Oncological Dispensary\"", "LocationCity":"Nizhny Novgorod", "LocationZip":"603081", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Institution of the Russian Academy of Medical Sciences Medical Radiology Research Center RAMS", "LocationCity":"Obninsk", "LocationZip":"249036", "LocationCountry":"Russian Federation" },{ "LocationFacility":"State Healthcare Institution SHI Pyatigorsk Oncological Dispensary", "LocationCity":"Pyatigorsk", "LocationZip":"357502", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Non-State Healthcare Institution NSHI", "LocationCity":"Saint-Petersburg", "LocationZip":"195271", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Saint-Petersburg State Healthcare Institution (SPb SHI) \"City Clinical Oncological Dispensary\"", "LocationCity":"Saint-Petersburg", "LocationZip":"197022", "LocationCountry":"Russian Federation" },{ "LocationFacility":"State Healthcare Institution (SHI)\"Voronezh Regional Clinical Oncological Dispensary\"", "LocationCity":"Voronezh", "LocationZip":"394000", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Fakultna nemocnica Nitra, Oddelenie radioterapie a klinickej onkologie", "LocationCity":"Nitra", "LocationZip":"95001", "LocationCountry":"Slovakia" },{ "LocationFacility":"Communal Institution \"Krivorizhskiy oncology dispensary\" of Dnipropetrovsk regional Council, Chemotherapy Department", "LocationCity":"Kriviy Rig", "LocationState":"Dnipropetrovsk region", "LocationZip":"50048", "LocationCountry":"Ukraine" },{ "LocationFacility":"Communal Institution \"Dnipropetrovsk Сity multiple-discipline Clinical Hospital 4\" of Dnipropetrovsk Regional Council", "LocationCity":"Dnipropetrovsk", "LocationZip":"49102", "LocationCountry":"Ukraine" },{ "LocationFacility":"Medical center of Limited Liability Company \"Inter\"", "LocationCity":"Lugansk", "LocationZip":"91000", "LocationCountry":"Ukraine" },{ "LocationFacility":"Lviv state oncological regional treatment-and-diagnostics center, Chemotherapy Department", "LocationCity":"Lviv", "LocationZip":"79031", "LocationCountry":"Ukraine" },{ "LocationFacility":"Communal Institution \"Odesa regional clinical hospital\", Mammology Center", "LocationCity":"Odesa", "LocationZip":"65025", "LocationCountry":"Ukraine" },{ "LocationFacility":"Vinnytsya Regional Clinical Oncological Center, Chemotherapy Department", "LocationCity":"Vinnitsya", "LocationZip":"21029", "LocationCountry":"Ukraine" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"26122726", "ReferenceType":"derived", "ReferenceCitation":"Blackwell K, Semiglazov V, Krasnozhon D, Davidenko I, Nelyubina L, Nakov R, Stiegler G, Singh P, Schwebig A, Kramer S, Harbeck N. Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Ann Oncol. 2015 Sep;26(9):1948-53. doi: 10.1093/annonc/mdv281. Epub 2015 Jun 28." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"The study started with a screening period of up to 21 days. During the screening period, the eligibility of the patients to participate in the study was assessed based on safety evaluations. After completion of the screening period, the patients were randomized to either EP2006 or US-licensed Neupogen® in four groups (see below).", "FlowRecruitmentDetails":"The study population consisted of women of 18 years or older with histologically proven breast cancer who were eligible for neoadjuvant or adjuvant treatment with TAC chemotherapy. The study was aimed to randomize a total of 192 patients in approximately 65 centers worldwide.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"EP2006", "FlowGroupDescription":"Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"EP2006 + Neupogen", "FlowGroupDescription":"Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Neupogen + EP2006", "FlowGroupDescription":"Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously" },{ "FlowGroupId":"FG003", "FlowGroupTitle":"Neupogen", "FlowGroupDescription":"Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"54" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"55" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"55" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"54" } ] } },{ "FlowMilestoneType":"Treated Cycle 1 EP2006", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"53" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"54" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"Treated Cycle 1 Neupogen", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"55" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"52" } ] } },{ "FlowMilestoneType":"Treated Cycle 2 EP2006", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"52" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"55" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"Treated Cycle 2 Neupogen", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"52" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"51" } ] } },{ "FlowMilestoneType":"Treated Cycle 3 EP2006", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"51" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"51" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"Treated Cycle 3 Neupogen", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"54" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"51" } ] } },{ "FlowMilestoneType":"Treated Cycle 4 EP2006", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"51" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"50" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"Treated Cycle 4 Neupogen", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"51" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"50" } ] } },{ "FlowMilestoneType":"Treated Cycle 5 EP2006", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"46" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"49" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"Treated Cycle 5 Neupogen", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"48" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"50" } ] } },{ "FlowMilestoneType":"Treated Cycle 6 EP2006", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"45" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"48" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"Treated Cycle 6 Neupogen", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"49" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"49" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"45" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"49" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"48" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"47" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"9" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"7" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Other Reason", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"4" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"The safety set consists of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"EP2006", "BaselineGroupDescription":"Patients remained on EP2006 (their initial treatment) throughout the study" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"EP2006 + Neupogen", "BaselineGroupDescription":"Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Neupogen + EP2006", "BaselineGroupDescription":"Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"Neupogen", "BaselineGroupDescription":"Patients remained on Neupogen (their initial treatment) throughout the study" },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"53" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"54" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"55" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"52" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"214" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"51.5", "BaselineMeasurementSpread":"11.16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"47.5", "BaselineMeasurementSpread":"11.64" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"49.7", "BaselineMeasurementSpread":"11.05" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"46.9", "BaselineMeasurementSpread":"10.91" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"48.9", "BaselineMeasurementSpread":"11.26" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"53" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"54" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"55" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"52" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"214" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mean Duration of Grade 4 Neutropenia During Cycle 1 of Chemotherapy", "OutcomeMeasureDescription":"Mean duration of severe neutropenia, defined as the mean number of consecutive days with Grade 4 neutropenia (ANC less than 0.5*10^9 cells/L)", "OutcomeMeasurePopulationDescription":"PP population", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Days", "OutcomeMeasureTimeFrame":"21 days (Cycle 1 of chemotherapy treatment)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EP2006 + EP2006 & Neupogen", "OutcomeGroupDescription":"All subjects randomized to receive either EP2006 in Cycle 1" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neupogen + Neupogen & EP2006", "OutcomeGroupDescription":"All subjects randomized to receive Neupogen in Cycle 1" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"101" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"103" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.17", "OutcomeMeasurementSpread":"1.11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.2", "OutcomeMeasurementSpread":"1.02" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000" ] }, "OutcomeAnalysisTestedNonInferiority":"Yes", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority or Equivalence", "OutcomeAnalysisNonInferiorityComment":"Non-inferiority limit: -1 day Power: 90% Confidence level: 97.5% Randomization ratio: 1:1 (EP2006:Neupogen)", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"0.04", "OutcomeAnalysisCIPctValue":"97.5", "OutcomeAnalysisCINumSides":"1-Sided", "OutcomeAnalysisCILowerLimit":"-0.26", "OutcomeAnalysisEstimateComment":"The one-sided 97.5% Confidence Interval: [-0.26, ∞)." } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Incidence of Febrile Neutropenia", "OutcomeMeasureDescription":"Incidence of febrile neutropenia by duraton within each cycle and across all cycles. Febrile neutropenia is defined as oral temperature greater than or equal 38.3°C while having an Absolute Neutrophil Count < 0.5*10^9 cells/L (both measured on the same day)", "OutcomeMeasurePopulationDescription":"SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"21 weeks/ 6 cycles", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EP2006", "OutcomeGroupDescription":"Patients remained on EP2006 (their initial treatment) throughout the study" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"EP2006 + Neupogen", "OutcomeGroupDescription":"Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Neupogen + EP2006", "OutcomeGroupDescription":"Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Neupogen", "OutcomeGroupDescription":"Patients remained on Neupogen (their initial treatment) throughout the study" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Total", "OutcomeGroupDescription":"All patients" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"52" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"52" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"55" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"51" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"210" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Cycle 1 - 0 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"50" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"49" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"54" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"204" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 1 - 1 Day duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 1 - 2 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2 - 0 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"52" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"55" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"209" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2 - 1 Day duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3 - 0 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"54" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"207" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4 - 0 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"50" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"50" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"202" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5 - 0 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"45" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"48" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"48" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"50" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"191" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5 - 1 Day duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6 - 0 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"43" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"48" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"48" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"49" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"188" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6 - 1 Day duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"All Cycles - 0 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"49" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"46" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"54" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"51" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"200" } ] } } ] } },{ "OutcomeClassTitle":"All Cycles - 1 Day duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"9" } ] } } ] } },{ "OutcomeClassTitle":"All Cycles - 2 Days duration", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"1" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Days of Fever", "OutcomeMeasureDescription":"Number of days of fever by cycle. Fever is defined as oral temperature greater than or equal to 38.3°C.", "OutcomeMeasurePopulationDescription":"PP-I (alternating Per-Protocol) set: randomized patients who completed all six chemotherapy cycles without major protocol violations.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"21 weeks/ 6 cycles", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EP2006", "OutcomeGroupDescription":"Patients remained on EP2006 (their initial treatment) throughout the study" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"EP2006 + Neupogen", "OutcomeGroupDescription":"Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Neupogen + EP2006", "OutcomeGroupDescription":"Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"Neupogen", "OutcomeGroupDescription":"Patients remained on Neupogen (their initial treatment) throughout the study" },{ "OutcomeGroupId":"OG004", "OutcomeGroupTitle":"Total", "OutcomeGroupDescription":"All patients" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"40" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"44" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"46" },{ "OutcomeDenomCountGroupId":"OG004", "OutcomeDenomCountValue":"175" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Cycle 1 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"41" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"42" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"46" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"168" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 1 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"36" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"43" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"44" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"46" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"169" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"44" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"44" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"45" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"173" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"44" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"43" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"46" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"173" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"44" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"43" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"45" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"172" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"39" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"44" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"44" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"46" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"173" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG004", "OutcomeMeasurementValue":"2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Depth of Absolute Neutrophil Count Nadir", "OutcomeMeasureDescription":"Depth of Absolute Neutrophil Count Nadir, defined as the patient's lowest Absolute Neutrophil Count in cycle 1", "OutcomeMeasurePopulationDescription":"FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"10^9 cells/L", "OutcomeMeasureTimeFrame":"Cycle 1/ 21 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EP2006 + EP2006 & Neupogen", "OutcomeGroupDescription":"All subjects randomized to receive either EP2006 in Cycle 1" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neupogen + Neupogen & EP2006", "OutcomeGroupDescription":"All subjects randomized to receive Neupogen in Cycle 1" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Total", "OutcomeGroupDescription":"All patients in Cycle 1" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"107" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"107" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"214" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.808", "OutcomeMeasurementSpread":"1.3694" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.744", "OutcomeMeasurementSpread":"1.2906" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0.776", "OutcomeMeasurementSpread":"1.3278" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to Absolute Neutrophil Count Recovery", "OutcomeMeasureDescription":"Time to Absolute Neutrophil Count recovery, defined as the time in days from Absolute Neutrophil Count nadir until the patient's Absolute Neutrophil Count increases to more or equal to 2*10^9 cells/L after the nadir in cycle 1", "OutcomeMeasurePopulationDescription":"FAS (full analysis) set: all patients who received at least one dose of study medication, analyzed according to randomization allocation. In the EP2006 + EP2006 & Neupogen group, one patient’s time to Absolute Neutrophil Count recovery could not be measured as the nadir was the last measured timepoint.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"Days", "OutcomeMeasureTimeFrame":"Cycle 1/ 21 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EP2006 + EP2006 & Neupogen", "OutcomeGroupDescription":"All subjects randomized to receive either EP2006 in Cycle 1" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neupogen + Neupogen & EP2006", "OutcomeGroupDescription":"All subjects randomized to receive Neupogen in Cycle 1" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Total", "OutcomeGroupDescription":"All patients in Cycle 1" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"106" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"107" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"213" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2.0", "OutcomeMeasurementLowerLimit":"0", "OutcomeMeasurementUpperLimit":"6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Frequency of Infections", "OutcomeMeasureDescription":"Frequency of infections by cycle and across all cycles", "OutcomeMeasurePopulationDescription":"SAF-I (alternating safety) set: patients who received at least one dose of study medication after Cycle 1. Comparison made for alternating versus non-alternating treatment groups.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"21 Weeks/ 6 cycles", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"EP2006 + Neupogen", "OutcomeGroupDescription":"All subjects randomized to receive either EP2006 or Neupogen." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"EP2006 & Neupogen + Neupogen & EP2006", "OutcomeGroupDescription":"All subjects randomized to receive EP2006 & Neupogen + Neupogen & EP2006." },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"Total", "OutcomeGroupDescription":"All patients in Cycle 1" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"103" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"107" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"210" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Cycle 1 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"102" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"104" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"206" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 1 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"100" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"102" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"202" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"8" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"102" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"107" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"209" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"101" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"104" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"205" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"101" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"106" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"207" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5 - Yes", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6 - No", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", 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} ] } },{ "OtherEventTerm":"Anaemia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"10", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"53" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"9", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"54" },{ "OtherEventStatsGroupId":"EG002", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"55" },{ "OtherEventStatsGroupId":"EG003", "OtherEventStatsNumEvents":"24", "OtherEventStatsNumAffected":"11", "OtherEventStatsNumAtRisk":"52" } ] } },{ "OtherEventTerm":"Leucopenia", "OtherEventOrganSystem":"Blood and lymphatic system disorders", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"21", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"53" },{ 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