{ "FullStudy":{ "Rank":217795, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516736", "OrgStudyIdInfo":{ "OrgStudyId":"LA-EP06-302" }, "Organization":{ "OrgFullName":"Sandoz", "OrgClass":"INDUSTRY" }, "BriefTitle":"Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Peg-Filgrastim", "OfficialTitle":"Pivotal Study in Breast Cancer Patients Investigating Efficacy and Safety of LA-EP2006 and Neulasta®", "Acronym":"PROTECT2" }, "StatusModule":{ "StatusVerifiedDate":"August 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 13, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 28, 2017", "ResultsFirstSubmitQCDate":"May 24, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 28, 2017", "ResultsFirstPostDateType":"Actual" }, "DispFirstSubmitDate":"November 20, 2014", "DispFirstSubmitQCDate":"December 12, 2014", "DispFirstPostDateStruct":{ "DispFirstPostDate":"January 5, 2015", "DispFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 1, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 30, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Sandoz", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Sandoz GmbH", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The study will assess the efficacy of LA-EP2006 compared to Neulasta® with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.", "DetailedDescription":"The Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare the proposed biosimilar LA-EP2006 with the reference pegfilgrastim in woman with early stage breast cancer receiving (neo)-adjuvant myelosuppressive chemotherapy. Patient received TAC (intravenous docetaxel 75mg/m^2, doxorubicin 50 mg/m^2, and cyclophosphamide 500mg/m^2) on day1 of each cycle, for six or more cycles. A total of 308 patients were randomized to LA-EP2006 (n=155) or reference Neulasta® (n=153). Treatment was given subcutaneously on day 2 of each cycle. The primary end point was the duration of severe neutropenia (DSN) during Cycle 1 (defined as number of consecutive days with absolute neutrophil count <0.5 × 10^9 cells/L). LA-EP2006 was equivalent to the reference product in DSN (difference: -0.16 days; 95% CI [-0.40, 0.08]). Further, LA-EP2006 and the reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chemotherapy-induced Neutropenia", "Breast Cancer" ] }, "KeywordList":{ "Keyword":[ "Pegfilgrastim", "G-CSF", "neutropenia", "breast cancer", "myelosuppressive chemotherapy" ] } }, "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":"308", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"LA-EP2006", "ArmGroupType":"Experimental", "ArmGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: LA-EP2006" ] } },{ "ArmGroupLabel":"Neulasta®", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Neulasta®" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"LA-EP2006", "InterventionDescription":"Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "LA-EP2006" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "pegfilgrastim" ] } },{ "InterventionType":"Drug", "InterventionName":"Neulasta®", "InterventionDescription":"Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Neulasta®" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "pegfilgrastim", "Neulasta" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy", "PrimaryOutcomeDescription":"Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).", "PrimaryOutcomeTimeFrame":"21 days (Cycle 1 of chemotherapy treatment)" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Incidence of Febrile Neutropenia (FN)", "SecondaryOutcomeDescription":"FN was defined as oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN (\"febrile neutropenia\", \"neutropenic sepsis\") were taken into account.", "SecondaryOutcomeTimeFrame":"across all cycles (18 weeks)" },{ "SecondaryOutcomeMeasure":"Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles", "SecondaryOutcomeDescription":"Fever was defined as an oral body temperature of ≥ 38.3°C. Fever episodes were described by maximum oral temperature and the number of patients who had fever at least once.", "SecondaryOutcomeTimeFrame":"across al cycles (18 weeks)" },{ "SecondaryOutcomeMeasure":"Depth of ANC Nadir in Cycle 1", "SecondaryOutcomeDescription":"The depth of ANC nadir was defined as the patient's lowest ANC (10^9 cells/L) in Cycle 1.", "SecondaryOutcomeTimeFrame":"Cycle 1 (3 weeks)" },{ "SecondaryOutcomeMeasure":"Number of Patients With ANC Nadir Per Day in Cycle 1", "SecondaryOutcomeDescription":"Numbers of patients with ANC nadir based per day during Cycle 1 are given.", "SecondaryOutcomeTimeFrame":"Cycle 1 (3 weeks)" },{ "SecondaryOutcomeMeasure":"Time to ANC Recovery in Days in Cycle 1", "SecondaryOutcomeDescription":"Time to absolute neutrophil count (ANC) recovery was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L after the nadir in Cycle 1.", "SecondaryOutcomeTimeFrame":"across Cycle 1 (3 weeks)" },{ "SecondaryOutcomeMeasure":"Frequency of Infections by Cycle and Across All Cycles", "SecondaryOutcomeDescription":"The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class \"Infections and Infestations\".", "SecondaryOutcomeTimeFrame":"across all cycles (18 weeks)" },{ "SecondaryOutcomeMeasure":"Mortality Due to Infection", "SecondaryOutcomeDescription":"Number of patients with death due to infections", "SecondaryOutcomeTimeFrame":"Study course (19 weeks)" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nhistologically proven breast cancer\neligible for six cycles of neoadjuvant or adjuvant chemotherapy\n\nExclusion Criteria:\n\nconcurrent or prior chemotherapy for breast cancer\nconcurrent or prior anti-cancer treatment for breast cancer such as endocrine therapy, immunotherapy, monoclonal antibodies, and/or biological therapy\nconcurrent prophylactic antibiotics\nprevious therapy with any G-CSF (granulocyte-colony stimulating factor) product\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 Biopharmaceutical Clinical Development", "OverallOfficialAffiliation":"Sandoz Biopharmaceuticals", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Hot Springs", "LocationState":"Arkansas", "LocationZip":"71913", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Jonesboro", "LocationState":"Arkansas", "LocationZip":"72401", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Corona", "LocationState":"California", "LocationZip":"92879", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Wichita", "LocationState":"Kansas", "LocationZip":"67214", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Mount Sterling", "LocationState":"Kentucky", "LocationZip":"40353", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Detroit", "LocationState":"Michigan", "LocationZip":"48202", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Bismarck", "LocationState":"North Dakota", "LocationZip":"58501", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Eugene", "LocationState":"Oregon", "LocationZip":"97401", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Germantown", "LocationState":"Tennessee", "LocationZip":"38138", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Newport News", "LocationState":"Virginia", "LocationZip":"23601", "LocationCountry":"United States" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Tucuman", "LocationZip":"4000", "LocationCountry":"Argentina" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Temuco", "LocationZip":"4810469", "LocationCountry":"Chile" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Chennai", "LocationZip":"600031", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Delhi", "LocationZip":"110092", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Gujarat", "LocationZip":"380009", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Hyderabad", "LocationZip":"50024", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Karamsad", "LocationZip":"388325", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Lucknow", "LocationZip":"226003", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Maharashtra", "LocationZip":"422004", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Mangalore", "LocationZip":"575001", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Mumbai", "LocationZip":"400010", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Pradesh", "LocationZip":"520002", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Surat", "LocationZip":"395010", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Vadodara", "LocationZip":"391760", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Vellore", "LocationZip":"632004", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Visakhapatnam", "LocationZip":"530017", "LocationCountry":"India" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Kelantan", "LocationZip":"16150", "LocationCountry":"Malaysia" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Nilai", "LocationZip":"71800", "LocationCountry":"Malaysia" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Penang", "LocationZip":"11200", "LocationCountry":"Malaysia" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Penang", "LocationZip":"11600", "LocationCountry":"Malaysia" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"San Juan", "LocationZip":"00910", "LocationCountry":"Puerto Rico" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"San Juan", "LocationZip":"00927", "LocationCountry":"Puerto Rico" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Arkhangelsk", "LocationZip":"163045", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Bashkortostan", "LocationZip":"450054", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Bryansk", "LocationZip":"241033", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Kazan", "LocationZip":"420029", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Krasnoyarsk", "LocationZip":"660133", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Moscow", "LocationZip":"115478", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Omsk", "LocationZip":"644046", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Orel", "LocationZip":"302020", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Orenburg", "LocationZip":"460021", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Rostov-na-Donu", "LocationZip":"344037", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"St Petersburg", "LocationZip":"197758", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"St. Petersburg", "LocationZip":"194017", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"St. Petersburg", "LocationZip":"194044", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"St. Petersburg", "LocationZip":"195271", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"St. Petersburg", "LocationZip":"197022", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Tomsk", "LocationZip":"634009", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Vladimir", "LocationZip":"600021", "LocationCountry":"Russian Federation" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Barcelona", "LocationZip":"08035", "LocationCountry":"Spain" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Madrid", "LocationZip":"28040", "LocationCountry":"Spain" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Santiago de Compostela", "LocationZip":"15706", "LocationCountry":"Spain" },{ "LocationFacility":"Sandoz Investigational Site", "LocationCity":"Valencia", "LocationZip":"46014", "LocationCountry":"Spain" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"27091420", "ReferenceType":"background", "ReferenceCitation":"Blackwell K, Donskih R, Jones CM, Nixon A, Vidal MJ, Nakov R, Singh P, Schaffar G, Gascón P, Harbeck N. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial. Oncologist. 2016 Jul;21(7):789-94. doi: 10.1634/theoncologist.2016-0011. Epub 2016 Apr 18." },{ "ReferencePMID":"28637287", "ReferenceType":"derived", "ReferenceCitation":"Blackwell K, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Harbeck N. Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Ann Oncol. 2017 Sep 1;28(9):2272-2277. doi: 10.1093/annonc/mdx303." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Undecided" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"LA-EP2006", "FlowGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Neulasta®", "FlowGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowMilestoneComment":"FAS/SAF full analysis set and safety analysis set", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"155" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"153" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowMilestoneComment":"1 more patient, Neulasta arm died but been withdrawn earlier, not included in participant flow-death", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"135" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"140" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"20" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"13" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"10" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" } ] } },{ "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"4" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Physician Decision", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Protocol Violation", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Other (not specified)", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Patient demographics (FAS set)", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"LA-EP2006", "BaselineGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Neulasta®", "BaselineGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"155" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"153" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"308" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"48.8", "BaselineMeasurementSpread":"10.50" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"49.1", "BaselineMeasurementSpread":"10.07" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"48.9", "BaselineMeasurementSpread":"10.27" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"155" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"153" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"308" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Ethnicity (NIH/OMB)", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"16" } ] } },{ "BaselineCategoryTitle":"Not Hispanic or Latino", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"145" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"147" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"292" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race (NIH/OMB)", "BaselineMeasureDescription":"The 2 patients with race “More than one race” were reported as Hispanic origin.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"American Indian or Alaska Native", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"62" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"58" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"120" } ] } },{ "BaselineCategoryTitle":"Native Hawaiian or Other Pacific Islander", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Black or African American", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } },{ "BaselineCategoryTitle":"White", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"90" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"93" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"183" } ] } },{ "BaselineCategoryTitle":"More than one race", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } },{ "BaselineCategoryTitle":"Unknown or Not Reported", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"BMI", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"kg/m^2", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"26.56", "BaselineMeasurementSpread":"5.771" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"26.49", "BaselineMeasurementSpread":"5.126" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"26.53", "BaselineMeasurementSpread":"5.450" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Time since diagnosis", "BaselineMeasurePopulationDescription":"For 2 patients in the Neulasta treatment group, the date of initial diagnosis was incomplete.", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"months", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"151" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"306" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1.28", "BaselineMeasurementLowerLimit":"0.2", "BaselineMeasurementUpperLimit":"42.3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1.28", "BaselineMeasurementLowerLimit":"0.3", "BaselineMeasurementUpperLimit":"11.2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1.28", "BaselineMeasurementLowerLimit":"0.2", "BaselineMeasurementUpperLimit":"42.3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Disease stage", "BaselineMeasureDescription":"TNM Disease stage was defined according to the American Joint Committee on Cancer (AJCC): (I) = T1 N0 M0 / T0 N1mi M0 / T1 N1mi M0; (II) = T0 N1 M0 / T1 N1 M0 / T2 N0 M0 / T2 N1 M0 / T3 N0 M0; (III) = T0 N2 M0 / T1 N2 M0 / T2 N2 M0 / T3 N1 M0 / T3 N2 M0 / T4 N0 M0 / T4 N1 M0 / T4 N2 M0 / AnyT N3 M0; (IV) = AnyT AnyN M1; T: size or direct extent of the primary tumour; N: degree of spread to regional lymph nodes; N1mi: Micrometastases (> 0.2 mm and/or > 200 cells, but none > 2.0 mm); M: presence of distant; https://www.cancer.gov/types/breast/hp/breast-treatment-pdq#link/_27", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"I", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"20" } ] } } ] } },{ "BaselineClassTitle":"II", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"70" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"61" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"131" } ] } } ] } },{ "BaselineClassTitle":"III", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"78" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"78" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"156" } ] } } ] } },{ "BaselineClassTitle":"IV", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Previous breast cancer surgery", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"154" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"152" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"306" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Previous radiotherapy", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"ECOG performance status", "BaselineMeasureDescription":"Grading according to ECOG:\n\n0: Fully active, able to carry on all pre-disease performance without restriction 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2: Ambulatory and capable of all self-care but unable to carry out any work activities up and about more than 50% of waking hours 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"0", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"117" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"110" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"227" } ] } } ] } },{ "BaselineClassTitle":"1", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"36" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"43" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"79" } ] } } ] } },{ "BaselineClassTitle":"2", "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"155" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"153" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"308" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"2" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mean Duration of Severe Neutropenia (DSN) During Cycle 1 of Chemotherapy", "OutcomeMeasureDescription":"Mean duration of severe neutropenia, defined as number of consecutive days with ANC <0.5 × 10^9/l (grade 4 neutropenia).", "OutcomeMeasurePopulationDescription":"Missing patients in FAS set due to blind data review meeting decision (no ANC profiles available). FAS set = full analysis set; PP set = per protocol set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"21 days (Cycle 1 of chemotherapy treatment)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LA-EP2006", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neulasta®", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"FAS", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"151" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"149" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.36", "OutcomeMeasurementSpread":"1.133" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.19", "OutcomeMeasurementSpread":"0.984" } ] } } ] } },{ "OutcomeClassTitle":"PP", "OutcomeClassDenomList":{ "OutcomeClassDenom":[ { "OutcomeClassDenomUnits":"Participants", "OutcomeClassDenomCountList":{ "OutcomeClassDenomCount":[ { "OutcomeClassDenomCountGroupId":"OG000", "OutcomeClassDenomCountValue":"148" },{ "OutcomeClassDenomCountGroupId":"OG001", "OutcomeClassDenomCountValue":"144" } ] } } ] }, "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.34", "OutcomeMeasurementSpread":"1.141" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.19", "OutcomeMeasurementSpread":"0.991" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:\n\nthat LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,\nthat LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1.", "OutcomeAnalysisNonInferiorityType":"Equivalence", "OutcomeAnalysisNonInferiorityComment":"The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.", "OutcomeAnalysisPValue":"0.05", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"The primary endpoints was analyzed with analysis of covariance (ANCOVA).", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"-0.16", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.40", "OutcomeAnalysisCIUpperLimit":"0.08" },{ "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"The primary objective of the study was to compare LA-EP2006 and Neulasta in terms of the DSN in Cycle 1. It was to be shown in a hierarchical way:\n\nthat LA-EP2006 is equivalent (margin: ±1 day) to Neulasta® with respect to DSN duration in Cycle 1 and, if this was successfully established,\nthat LA-EP2006 is non-inferior (margin: -0.6 days) to Neulasta® with respect to DSN duration in Cycle 1.", "OutcomeAnalysisNonInferiorityType":"Non-Inferiority", "OutcomeAnalysisNonInferiorityComment":"The testing procedure was set up in a hierarchical structure, where first equivalence between LA-EP2006 and Neulasta® was assessed (margin ±1 day) and only if this was successfully established, non-inferiority between the two products was tested using a tighter margin of -0.6 days.", "OutcomeAnalysisPValue":"0.05", "OutcomeAnalysisStatisticalMethod":"ANCOVA", "OutcomeAnalysisStatisticalComment":"The primary endpoints was analyzed with analysis of covariance (ANCOVA).", "OutcomeAnalysisParamType":"Mean Difference (Net)", "OutcomeAnalysisParamValue":"-0.16", "OutcomeAnalysisCIPctValue":"95", "OutcomeAnalysisCINumSides":"2-Sided", "OutcomeAnalysisCILowerLimit":"-0.40", "OutcomeAnalysisCIUpperLimit":"0.08" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Incidence of Febrile Neutropenia (FN)", "OutcomeMeasureDescription":"FN was defined as oral temperature ≥ 38.3°C while having an absolute neutrophil count (ANC) < 0.5 × 10^9 cells/L. Serious treatment-emergent adverse events (TEAEs) were reconciled with the fever and ANC results recorded in the patient diary and CRF and therefore only the serious TEAEs of FN (\"febrile neutropenia\", \"neutropenic sepsis\") were taken into account.", "OutcomeMeasurePopulationDescription":"FAS set = full analysis set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"across all cycles (18 weeks)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LA-EP2006", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neulasta®", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Cycle 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"All cycles (at least on incidence)", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"20" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Patients With at Least One Episode of Fever by Cycle and Across All Cycles", "OutcomeMeasureDescription":"Fever was defined as an oral body temperature of ≥ 38.3°C. Fever episodes were described by maximum oral temperature and the number of patients who had fever at least once.", "OutcomeMeasurePopulationDescription":"Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"across al cycles (18 weeks)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LA-EP2006", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neulasta®", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Cycle 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"17" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Overall", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"32" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"35" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Depth of ANC Nadir in Cycle 1", "OutcomeMeasureDescription":"The depth of ANC nadir was defined as the patient's lowest ANC (10^9 cells/L) in Cycle 1.", "OutcomeMeasurePopulationDescription":"FAS set = full analysis set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"10^9 cells/L", "OutcomeMeasureTimeFrame":"Cycle 1 (3 weeks)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LA-EP2006", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neulasta®", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"152" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"149" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.490", "OutcomeMeasurementSpread":"0.7205" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0.444", "OutcomeMeasurementSpread":"0.5684" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Patients With ANC Nadir Per Day in Cycle 1", "OutcomeMeasureDescription":"Numbers of patients with ANC nadir based per day during Cycle 1 are given.", "OutcomeMeasurePopulationDescription":"FAS set = full analysis set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Cycle 1 (3 weeks)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LA-EP2006", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neulasta®", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Days 1-5", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Day 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8" } ] } } ] } },{ "OutcomeClassTitle":"Day 7", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"117" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"109" } ] } } ] } },{ "OutcomeClassTitle":"Day 8", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"30" } ] } } ] } },{ "OutcomeClassTitle":"Day 9", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Days 10-15", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"not definable", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Time to ANC Recovery in Days in Cycle 1", "OutcomeMeasureDescription":"Time to absolute neutrophil count (ANC) recovery was defined as the time in days from ANC nadir until the patient's ANC had increased to ≥ 2 × 10^9 cells/L after the nadir in Cycle 1.", "OutcomeMeasurePopulationDescription":"FAS set = full analysis set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"across Cycle 1 (3 weeks)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LA-EP2006", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neulasta®", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.11", "OutcomeMeasurementSpread":"0.889" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.04", "OutcomeMeasurementSpread":"0.951" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Frequency of Infections by Cycle and Across All Cycles", "OutcomeMeasureDescription":"The number of patients with infections was recorded for each cycle and across all cycles. Infections were identified by the AE documentation page selecting all events coded with System Organ Class \"Infections and Infestations\".", "OutcomeMeasurePopulationDescription":"Patients with more than 1 event during the study (overall) are counted only once. FAS set = full analysis set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"across all cycles (18 weeks)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LA-EP2006", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neulasta®", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Cycle 1", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 2", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 4", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 5", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6" } ] } } ] } },{ "OutcomeClassTitle":"Cycle 6", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Overall", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"32" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mortality Due to Infection", "OutcomeMeasureDescription":"Number of patients with death due to infections", "OutcomeMeasurePopulationDescription":"FAS set = full analysis set", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Study course (19 weeks)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"LA-EP2006", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neulasta®", "OutcomeGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"155" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"153" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeCategoryTitle":"Yes", "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } },{ "OutcomeCategoryTitle":"No", "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"155" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"153" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"3", "EventsTimeFrame":"Patients were followed for a 4-week safety period from the last administration of pegfilgrastim.", "EventsDescription":"Severity of treatment-emergent adverse events (TEAEs) was captured by CTCAE (Common Toxicology Criteria for Adverse Events) grading. SAF set = safety analysis set was used", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"LA-EP2006", "EventGroupDescription":"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.\n\nLA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.", "EventGroupDeathsNumAffected":"3", "EventGroupDeathsNumAtRisk":"155", "EventGroupSeriousNumAffected":"29", "EventGroupSeriousNumAtRisk":"155", "EventGroupOtherNumAffected":"147", "EventGroupOtherNumAtRisk":"155" },{ "EventGroupId":"EG001", "EventGroupTitle":"Neulasta®", "EventGroupDescription":"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.\n\nNeulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.", "EventGroupDeathsNumAffected":"2", "EventGroupDeathsNumAtRisk":"153", "EventGroupSeriousNumAffected":"32", "EventGroupSeriousNumAtRisk":"153", "EventGroupOtherNumAffected":"144", "EventGroupOtherNumAtRisk":"153" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Febrile neutropenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"16", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"19", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Neutropenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"6", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Thrombocytopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Anemia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Abdominal pain", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Diarrhea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Vomiting", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Abdominal discomfort", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Constipation", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Gastric ulcer hemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Gastritis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Nausea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Peptic ulcer", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Proctalgia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Stomatitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Gastroenteritis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Bronchitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Clostridium difficile infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Mastitis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Neutropenic sepsis", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Staphylococcal infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Upper respiratory tract infection", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Asthenia", "SeriousEventOrganSystem":"General disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Pyrexia", "SeriousEventOrganSystem":"General disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Non-cardiac chest pain", "SeriousEventOrganSystem":"General disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Atrial fibrillation", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Cardiac arrest", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Cardio-respiratory arrest", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Pericardial hemorrhage", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"155" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"153" } ] } },{ "SeriousEventTerm":"Pulmonary embolism", "SeriousEventOrganSystem":"Respiratory, thoracic and mediastinal disorders", 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