{ "FullStudy":{ "Rank":217871, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515748", "OrgStudyIdInfo":{ "OrgStudyId":"DOCET_R_05153" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"U1111-1127-0246", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"UTN" },{ "SecondaryId":"EFC13833", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Sanofi" } ] }, "Organization":{ "OrgFullName":"Sanofi", "OrgClass":"INDUSTRY" }, "BriefTitle":"Docetaxel+Oxaliplatin+S-1 (DOS) Regimen as Neoadjuvant Chemotherapy in Advanced Gastric Cancer", "OfficialTitle":"A Phase III, Open-labelled, Randomised Study of Neoadjuvant Docetaxel+Oxaliplatin+S-1 (DOS) + Surgery + Adjuvant S-1 Versus Surgery + Adjuvant S-1 in Patients With Resectable Advanced Gastric Cancer", "Acronym":"PRODIGY" }, "StatusModule":{ "StatusVerifiedDate":"February 2020", "OverallStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 30, 2011", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 21, 2019", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2, 2022", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 20, 2020", "ResultsFirstSubmitQCDate":"February 28, 2020", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 2, 2020", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"February 28, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 2, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Sanofi", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Primary Objective:\n\n- To compare the 3-year progression free survival (PFS) in the two treatment arms.\n\nSecondary Objectives:\n\nOverall survival (OS).\nPostoperative pathological stage and R0 (complete) resection rate.\nSafety: Toxicities associated with neoadjuvant chemotherapy, surgery, morbidity/mortality, toxicity of adjuvant chemotherapy.", "DetailedDescription":"Participants in the neoadjuvant chemotherapy arm were treated for 3 cycles (1 cycle is 21 days) before surgery and treated for a year with S-1. Participants in the adjuvant chemotherapy arm underwent surgery and were treated for a year with S-1. All participants will be followed during and after the study treatment until death or disease progression, whichever comes first." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Gastric Cancer" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"530", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Surgery + Adjuvant Chemotherapy (SC)", "ArmGroupType":"Other", "ArmGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 milligrams per square meter (mg/m^2) administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after End-of-Treatment (EOT) until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)" ] } },{ "ArmGroupLabel":"Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC)", "ArmGroupType":"Experimental", "ArmGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 intravenously (IV) for greater than or equal to (>=)1 hour (hr) on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Docetaxel (XRP6976)", "Drug: Oxaliplatin (SR96669)", "Drug: S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Docetaxel (XRP6976)", "InterventionDescription":"Pharmaceutical form:solution for infusion Route of administration: intravenous", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC)" ] } },{ "InterventionType":"Drug", "InterventionName":"Oxaliplatin (SR96669)", "InterventionDescription":"Pharmaceutical form:solution for infusion Route of administration: intravenous", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC)" ] } },{ "InterventionType":"Drug", "InterventionName":"S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil)", "InterventionDescription":"Pharmaceutical form:Tablet Route of administration: Oral", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC)", "Surgery + Adjuvant Chemotherapy (SC)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1", "PrimaryOutcomeDescription":"PFS was defined as the time from randomization to objective tumor progression, or recurrence or death. Progressive disease (PD) was defined as: 1) In Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Arm, PD was determined according to the RECIST 1.1 Criteria during the neo-adjuvant chemotherapy period; 2) Irrespective of curative resection, if an intraoperative distant metastasis was observed or a distant metastasis was reported from pathology, it was considered PD; 3) If residual cancer cells were visually identified at the resection margin during surgery but could not be completely resected (R2), it was considered PD; 4) If residual cancer cells were finally confirmed at the resection margin during postoperative histology (R1), it was considered PD; 5) In case of finding a recurrence/distant metastasis or a new lesion during follow-up after R0 complete resection, it was defined as the first tumor assessment date when it was observed.", "PrimaryOutcomeTimeFrame":"3 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Overall Survival (OS)", "SecondaryOutcomeDescription":"Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (January 2023).", "SecondaryOutcomeTimeFrame":"Up to 11 years" },{ "SecondaryOutcomeMeasure":"Number of Participants With Post-Operative Pathological Stage Response", "SecondaryOutcomeDescription":"TNM pathological stage was determined according to standardized histopathology and the American Joint Committee on Cancer (AJCC) staging system 7th Edition (Stages 0,IA,IB,IIA,IIB,IIIA,IIIB,IIIC and IV). Stage 0=carcinoma in situ with no metastatic potential; Stage IA=T1N0M0; Stage IB=T2N0M0,T1N1M0; Stage IIA=T3N0M0,T2N1M0,T1N2M0;Stage IIB=T4aN0M0,T3N1M0,T2N2M0,T1N3M0;Stage IIIA=T4aN1M0,T3N2M0,T2N3M0;Stage IIIB=T4bN0-1M0,T4aN2M0,T3N3M0;Stage IIIC=T4bN2-3M0, T4aN3M0 and Stage IV= distant metastases (M1) at diagnosis; where \"T\" denotes \"tumor size\" where T1: tumor invades lamina propria, muscularis mucosae, or submucosa; T2: invades muscularis propria; T3: invasion of subserosa; T4: T4a: penetrate serosa (visceral peritoneum) T4b: invade adjacent tissue and \" N\" denotes \"nodes affected\" where N1:1-2 positive lymph nodes; N2:3-6 positive lymph nodes; N3: 7 or more positive lymph nodes and \"M\" denotes metastases where M0: no distant metastases. Higher stages indicates worse outcome.", "SecondaryOutcomeTimeFrame":"Up to 8 years" },{ "SecondaryOutcomeMeasure":"Percentage of Participants With R0 Resection", "SecondaryOutcomeDescription":"Tumor condition was explained according to the Residual Tumor (R) Classification: R0; No residual cancer (negative cross-section), R1; Microscopically observed residual cancer (positive cross-section), R2; Macroscopically observed residual cancer.", "SecondaryOutcomeTimeFrame":"Up to 8 years" },{ "SecondaryOutcomeMeasure":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)", "SecondaryOutcomeDescription":"TEAEs were defined as adverse events (AE) that appeared or worsened during the treatment period (up to 30 days after the last dose of the investigational product). SAE was an AE or adverse drug reaction at any dose of the investigational product that corresponded to one of the following: resulting in death or is life threatening; requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability of dysfunction; resulting in congenital anomaly or birth defect; important medical event.", "SecondaryOutcomeTimeFrame":"From randomization up to 30 days after last dose of study drug (maximum duration: up to 8 years)" },{ "SecondaryOutcomeMeasure":"Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3", "SecondaryOutcomeDescription":"NCI-CTCAE version 4.03 was used to determine Grade(Gr),where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Hemoglobin(Hb)(Anemia) were based on Gr1:0-2g/dL above upper limit of normal(ULN);Gr2: incr. in >2-4g/dL above ULN; Gr3:incr. in >4gm/dL above ULN. White blood cell (WBC) decreased: Gr1:100,000/mm^3, Gr4:clinical manifestations of leucostasis;Gr5:Death. Abnormal Neutrophil count (ANC):- Gr1:=3", "SecondaryOutcomeDescription":"NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Sodium (Hyponatremia) were based on Gr1: ULN-150 mmol/L; Gr2: >150-155 mmol/L; Gr3:>155-160 mmol/L;hospitalization; Gr4: >160 mmol/L; life-threatening consequences; Gr5: Death. Potassium (Hypokalemia): Gr 1: ULN-5.5 mmol/L; Gr2: >5.5-6.0 mmol/L; Gr3: >6.0-7.0 mmol/L; hospitalization indicated; Gr4: >7.0 mmol/L; life-threatening consequences; Gr5: Death.", "SecondaryOutcomeTimeFrame":"From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)" },{ "SecondaryOutcomeMeasure":"Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3", "SecondaryOutcomeDescription":"NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Calcium(Hypocalcemia) were based on Gr1: Corrected serum calcium of ULN -11.5 mg/dL; Gr2: Corrected serum calcium of >11.5-12.5 mg/dL; Gr3: Corrected serum calcium of >12.5-13.5 mg/dL; Gr4: Corrected serum calcium of >13.5 mg/dL;Gr5:Death. Creatinine increased: Gr 1: >1-1.5*baseline; >ULN-1.5*ULN; Gr2: >1.5-3.0*baseline; >1.5-3.0*ULN; Gr3: >3.0 baseline; >3.0-6.0*ULN; Gr4: >6.0 x ULN. Albumin(Hypoalbuminemia): Gr 1: =3", "SecondaryOutcomeDescription":"NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Aspartate and alanine aminotransferase increased were based on Gr1: >ULN-3.0*ULN; Gr2: >3.0-5.0*ULN; Gr3: >5.0-20.0*ULN; Gr4: >20.0*ULN. Blood bilirubin increased: Gr1: >ULN-1.5*ULN; Gr2 >1.5-3.0*ULN; Gr3: >3.0-10.0*ULN; Gr4: >10.0*ULN. Alkaline phosphatase increased: Gr1: >ULN-2.5*ULN; Gr2: >2.5-5.0*ULN; Gr3: >5.0-20.0*ULN; Gr4: >20.0*ULN. Glucose (Hypoglycemia): Gr 1: ULN-160 mg/dL; Gr2: Fasting glucose value >160-250 mg/dL; Gr3: >250-500 mg/dL; Gr4: >500 mg/dL; Gr5: Death.", "SecondaryOutcomeTimeFrame":"From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)" },{ "SecondaryOutcomeMeasure":"Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3", "SecondaryOutcomeDescription":"NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3: severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Creatinine Clearance(Chronic kidney disease) were based on: Gr 1: estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) =] 8 in hour axis).\nSigned informed consent.\n\nExclusion criteria:\n\nAged less than (<) 20 years or >= 76 years. Performance status >=2 in Eastern Cooperative Oncology Group (ECOG) scale\nThe participants who had the history of other malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix which had been already successfully treated.\nPrevious surgery on neoplasm of stomach.\nParticipants who did not completely recovered from surgery.\nDistant metastases (M1) to other organs including distant nodal groups (retropancreatic, para-aortic, portal, retroperitoneal, mesenteric node). severe/unstable angina, coronary artery bypass graft, congestive heart failure, transient ischemic attack within 6 months prior to enrollment in the study.\nAny previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy, for the currently treated gastric cancer.\nParticipants with active active infection or sepsis.\nIntolerance of oral taking or malabsorption: lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of S-1. Ileus, chronic inflammatory intestinal disease or extensive resection of the small intestine and other disorders which limit drug resorption. This includes gastric dumping syndrome, indications of accelerated passage through the small intestine and indications of resorption disorders after intestinal surgery.\nGreater than or equal to grade 2 severe tumour haemorrhage.\nSimultaneous participation in another study, or participation in another study within 4 weeks of commencement of this study.\nPregnant or lactating participants.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Yoon-Koo KANG, MD, PhD", "OverallOfficialAffiliation":"Asan Medical Center", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Administrative Office", "LocationCity":"Seoul", "LocationCountry":"Korea, Republic of" } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"Yes", "IPDSharingDescription":"Qualified researchers may request access to participant level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Participant level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com /" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Total of 530 participants were enrolled and randomized in study. Assignment was done using Interactive Web-Response System (IWRS) in 1:1 to treatment arms. Randomization was stratified by site and Tumor size, Lymph Nodes affected, Metastases (TNM) [T2/N+,T3-4/N+,T4/N-] stage. Results are reported based on primary completion date of 21 January 2019.", "FlowRecruitmentDetails":"The study was conducted at 19 sites in Korea. A total of 693 participants were screened between 30 December 2011 to 02 January 2019, of which, 163 were screen failures. Screen failures were mainly due to inclusion criteria not met.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "FlowGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 milligrams per square meter (mg/m^2) administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after End-of-Treatment (EOT) until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "FlowGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 intravenously (IV) for greater than or equal to (>=)1 hour (hr) on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowMilestoneComment":"Randomized", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"264" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"266" } ] } },{ "FlowMilestoneType":"Treated", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"195" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"241" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"144" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"131" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"120" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"135" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"32" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"41" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"4" } ] } },{ "FlowDropWithdrawType":"Ongoing", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"86" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"90" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"Analysis was performed on Intent-to-Treat (ITT) population which included all randomized participants.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "BaselineGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "BaselineGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"264" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"266" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"530" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"264" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"266" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"530" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"57.28", "BaselineMeasurementSpread":"10.09" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"57.11", "BaselineMeasurementSpread":"10.03" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"57.19", "BaselineMeasurementSpread":"10.05" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"264" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"266" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"530" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"50" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"59" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"109" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"214" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"207" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"421" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race and Ethnicity Not Collected", "BaselineMeasurePopulationDescription":"Race and Ethnicity were not collected from any participant.", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassDenomList":{ "BaselineClassDenom":[ { "BaselineClassDenomUnits":"Participants", "BaselineClassDenomCountList":{ "BaselineClassDenomCount":[ { "BaselineClassDenomCountGroupId":"BG000", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG001", "BaselineClassDenomCountValue":"0" },{ "BaselineClassDenomCountGroupId":"BG002", "BaselineClassDenomCountValue":"0" } ] } } ] }, "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants With 3-Year Progression-Free Survival (PFS), as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)1.1", "OutcomeMeasureDescription":"PFS was defined as the time from randomization to objective tumor progression, or recurrence or death. Progressive disease (PD) was defined as: 1) In Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Arm, PD was determined according to the RECIST 1.1 Criteria during the neo-adjuvant chemotherapy period; 2) Irrespective of curative resection, if an intraoperative distant metastasis was observed or a distant metastasis was reported from pathology, it was considered PD; 3) If residual cancer cells were visually identified at the resection margin during surgery but could not be completely resected (R2), it was considered PD; 4) If residual cancer cells were finally confirmed at the resection margin during postoperative histology (R1), it was considered PD; 5) In case of finding a recurrence/distant metastasis or a new lesion during follow-up after R0 complete resection, it was defined as the first tumor assessment date when it was observed.", "OutcomeMeasurePopulationDescription":"Full Analysis Set (FAS):included all randomized participants who satisfied inclusion/exclusion criteria and had at least one tumor assessment after baseline visit (Day 0).While the CSC Arm included participants who administered at least one dose of Docetaxel+Oxaliplatin+S-1 investigational products, the SC Arm included participants who had surgery.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"3 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "OutcomeGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "OutcomeGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"246" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"233" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"60.22", "OutcomeMeasurementLowerLimit":"53.53", "OutcomeMeasurementUpperLimit":"66.26" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"66.82", "OutcomeMeasurementLowerLimit":"60.13", "OutcomeMeasurementUpperLimit":"72.65" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisGroupDescription":"Analysis was performed using Kaplan-Meier method. Comparison was stratified based on site and TNM classification (T4/N-, T2/N+, T3-4/N+).", "OutcomeAnalysisNonInferiorityType":"Superiority", "OutcomeAnalysisPValue":"0.0154", "OutcomeAnalysisPValueComment":"Threshold for statistical significance at 0.05.", "OutcomeAnalysisStatisticalMethod":"Log Rank" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Overall Survival (OS)", "OutcomeMeasureDescription":"Data for this outcome measure will be reported at the time of anticipated last participant last visit results posting (January 2023).", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureAnticipatedPostingDate":"01/2023", "OutcomeMeasureTimeFrame":"Up to 11 years", "OutcomeMeasureDenomUnitsSelected":"Participants" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Post-Operative Pathological Stage Response", "OutcomeMeasureDescription":"TNM pathological stage was determined according to standardized histopathology and the American Joint Committee on Cancer (AJCC) staging system 7th Edition (Stages 0,IA,IB,IIA,IIB,IIIA,IIIB,IIIC and IV). Stage 0=carcinoma in situ with no metastatic potential; Stage IA=T1N0M0; Stage IB=T2N0M0,T1N1M0; Stage IIA=T3N0M0,T2N1M0,T1N2M0;Stage IIB=T4aN0M0,T3N1M0,T2N2M0,T1N3M0;Stage IIIA=T4aN1M0,T3N2M0,T2N3M0;Stage IIIB=T4bN0-1M0,T4aN2M0,T3N3M0;Stage IIIC=T4bN2-3M0, T4aN3M0 and Stage IV= distant metastases (M1) at diagnosis; where \"T\" denotes \"tumor size\" where T1: tumor invades lamina propria, muscularis mucosae, or submucosa; T2: invades muscularis propria; T3: invasion of subserosa; T4: T4a: penetrate serosa (visceral peritoneum) T4b: invade adjacent tissue and \" N\" denotes \"nodes affected\" where N1:1-2 positive lymph nodes; N2:3-6 positive lymph nodes; N3: 7 or more positive lymph nodes and \"M\" denotes metastases where M0: no distant metastases. Higher stages indicates worse outcome.", "OutcomeMeasurePopulationDescription":"Analysis was performed on FAS population. Here, ‘Overall number of participants analyzed’ = participants evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Up to 8 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "OutcomeGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "OutcomeGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"246" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"222" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Stage 0", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"23" } ] } } ] } },{ "OutcomeClassTitle":"Stage IA", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"32" } ] } } ] } },{ "OutcomeClassTitle":"Stage IB", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"18" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"23" } ] } } ] } },{ "OutcomeClassTitle":"Stage IIA", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"30" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"47" } ] } } ] } },{ "OutcomeClassTitle":"Stage IIB", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"25" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"36" } ] } } ] } },{ "OutcomeClassTitle":"Stage IIIA", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"35" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"18" } ] } } ] } },{ "OutcomeClassTitle":"Stage IIIB", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"49" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"24" } ] } } ] } },{ "OutcomeClassTitle":"Stage IIIC", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"47" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14" } ] } } ] } },{ "OutcomeClassTitle":"Stage IV", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"33" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants With R0 Resection", "OutcomeMeasureDescription":"Tumor condition was explained according to the Residual Tumor (R) Classification: R0; No residual cancer (negative cross-section), R1; Microscopically observed residual cancer (positive cross-section), R2; Macroscopically observed residual cancer.", "OutcomeMeasurePopulationDescription":"Analysis was performed on FAS population. Here, ‘overall number of participants analyzed’ = participants evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Up to 8 years", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "OutcomeGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "OutcomeGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"246" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"222" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"85.77", "OutcomeMeasurementLowerLimit":"81.41", "OutcomeMeasurementUpperLimit":"90.14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"96.40", "OutcomeMeasurementLowerLimit":"93.94", "OutcomeMeasurementUpperLimit":"98.85" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)", "OutcomeMeasureDescription":"TEAEs were defined as adverse events (AE) that appeared or worsened during the treatment period (up to 30 days after the last dose of the investigational product). SAE was an AE or adverse drug reaction at any dose of the investigational product that corresponded to one of the following: resulting in death or is life threatening; requiring in-patient hospitalization or prolongation of existing hospitalization; resulting in persistent or significant disability of dysfunction; resulting in congenital anomaly or birth defect; important medical event.", "OutcomeMeasurePopulationDescription":"Analysis was performed on safety population which included participants who were administered at least one dose of the investigational product.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"From randomization up to 30 days after last dose of study drug (maximum duration: up to 8 years)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "OutcomeGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "OutcomeGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"195" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"241" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Any TEAE", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"190" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"237" } ] } } ] } },{ "OutcomeClassTitle":"Any treatment emergent SAE", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"57" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"102" } ] } } ] } },{ "OutcomeClassTitle":"TEAEs leading to permanent discontinuation", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"25" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Shift of Laboratory Parameters (Hematology) From Baseline Grade to Worst National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade >=3", "OutcomeMeasureDescription":"NCI-CTCAE version 4.03 was used to determine Grade(Gr),where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Hemoglobin(Hb)(Anemia) were based on Gr1:0-2g/dL above upper limit of normal(ULN);Gr2: incr. in >2-4g/dL above ULN; Gr3:incr. in >4gm/dL above ULN. White blood cell (WBC) decreased: Gr1:100,000/mm^3, Gr4:clinical manifestations of leucostasis;Gr5:Death. Abnormal Neutrophil count (ANC):- Gr1:= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"195" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"241" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Hb(Anemia) Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb(Anemia) Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Hb(Anemia) Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Hb(Anemia) Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb(Anemia) Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb(Anemia) Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb increased Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb increased Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb increased Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb increased Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb increased Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hb increased Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC decreased Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8" } ] } } ] } },{ "OutcomeClassTitle":"WBC decreased Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"WBC decreased Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC decreased Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC decreased Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC decreased Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC (Leukocytosis) Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"WBC (Leukocytosis) Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC (Leukocytosis) Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC (Leukocytosis) Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC (Leukocytosis) Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"WBC (Leukocytosis) Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"ANC Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"40" } ] } } ] } },{ "OutcomeClassTitle":"ANC Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"ANC Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"ANC Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"ANC Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"ANC Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Platelet count decreased Gr0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5" } ] } } ] } },{ "OutcomeClassTitle":"Platelet count decreased Gr1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Platelet count decreased Gr2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Platelet count decreased Gr3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Platelet count decreased Gr4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Platelet count decreased Gr5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Shift of Laboratory Parameters (Sodium and Potassium Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3", "OutcomeMeasureDescription":"NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Sodium (Hyponatremia) were based on Gr1: ULN-150 mmol/L; Gr2: >150-155 mmol/L; Gr3:>155-160 mmol/L;hospitalization; Gr4: >160 mmol/L; life-threatening consequences; Gr5: Death. Potassium (Hypokalemia): Gr 1: ULN-5.5 mmol/L; Gr2: >5.5-6.0 mmol/L; Gr3: >6.0-7.0 mmol/L; hospitalization indicated; Gr4: >7.0 mmol/L; life-threatening consequences; Gr5: Death.", "OutcomeMeasurePopulationDescription":"Analysis was performed on safety population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureCalculatePct":"No", "OutcomeMeasureTimeFrame":"From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "OutcomeGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "OutcomeGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"195" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"241" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Hyponatremia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"7" } ] } } ] } },{ "OutcomeClassTitle":"Hyponatremia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyponatremia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyponatremia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Hyponatremia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyponatremia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypernatremia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypernatremia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypernatremia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypernatremia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypernatremia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypernatremia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypokalemia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Hypokalemia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Hypokalemia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypokalemia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypokalemia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypokalemia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyperkalemia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Hyperkalemia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyperkalemia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyperkalemia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyperkalemia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyperkalemia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Shift of Laboratory Parameters (Calcium, Creatinine and Albumin Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3", "OutcomeMeasureDescription":"NCI-CTCAE version 4.03 was used to determine Gr,where Gr refers to severity of AE:Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate;minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Calcium(Hypocalcemia) were based on Gr1: Corrected serum calcium of ULN -11.5 mg/dL; Gr2: Corrected serum calcium of >11.5-12.5 mg/dL; Gr3: Corrected serum calcium of >12.5-13.5 mg/dL; Gr4: Corrected serum calcium of >13.5 mg/dL;Gr5:Death. Creatinine increased: Gr 1: >1-1.5*baseline; >ULN-1.5*ULN; Gr2: >1.5-3.0*baseline; >1.5-3.0*ULN; Gr3: >3.0 baseline; >3.0-6.0*ULN; Gr4: >6.0 x ULN. Albumin(Hypoalbuminemia): Gr 1: = 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"195" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"241" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Hypocalcemia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypocalcemia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypocalcemia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypocalcemia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypocalcemia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypocalcemia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypercalcemia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Hypercalcemia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypercalcemia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypercalcemia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypercalcemia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypercalcemia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine increased Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine increased Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine increased Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine increased Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine increased Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine increased Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoalbuminemia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Hypoalbuminemia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoalbuminemia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoalbuminemia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoalbuminemia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoalbuminemia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Shift of Laboratory Parameters (Aspartate Aminotransferase, Alanine Aminotransferase,Blood Bilirubin,Alkaline Phosphatase and Glucose Levels) From Baseline Grade to Worst NCI-CTCAE Grade >=3", "OutcomeMeasureDescription":"NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1:mild; asymptomatic/mild symptoms; Gr 2:moderate; minimal; Gr 3:severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Aspartate and alanine aminotransferase increased were based on Gr1: >ULN-3.0*ULN; Gr2: >3.0-5.0*ULN; Gr3: >5.0-20.0*ULN; Gr4: >20.0*ULN. Blood bilirubin increased: Gr1: >ULN-1.5*ULN; Gr2 >1.5-3.0*ULN; Gr3: >3.0-10.0*ULN; Gr4: >10.0*ULN. Alkaline phosphatase increased: Gr1: >ULN-2.5*ULN; Gr2: >2.5-5.0*ULN; Gr3: >5.0-20.0*ULN; Gr4: >20.0*ULN. Glucose (Hypoglycemia): Gr 1: ULN-160 mg/dL; Gr2: Fasting glucose value >160-250 mg/dL; Gr3: >250-500 mg/dL; Gr4: >500 mg/dL; Gr5: Death.", "OutcomeMeasurePopulationDescription":"Analysis was performed on safety population.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureCalculatePct":"No", "OutcomeMeasureTimeFrame":"From Baseline up to 30 days after last dose of study drug (maximum duration: up to 8 years)", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "OutcomeGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "OutcomeGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"195" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"241" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Aspartate aminotransferase Gr0 at Baseline toGr>=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Aspartate aminotransferase Gr1 at Baseline toGr>=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Aspartate aminotransferase Gr2 at Baseline toGr>=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Aspartate aminotransferase Gr3 at Baseline toGr>=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Aspartate aminotransferase Gr4 at Baseline toGr>=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Aspartate aminotransferase Gr5 at Baseline toGr>=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alanine aminotransferase Gr0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Alanine aminotransferase Gr1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alanine aminotransferase Gr2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alanine aminotransferase Gr3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alanine aminotransferase Gr4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alanine aminotransferase Gr5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Bilirubin increased Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"4" } ] } } ] } },{ "OutcomeClassTitle":"Bilirubin increased Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Bilirubin increased Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Bilirubin increased Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Bilirubin increased Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Bilirubin increased Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alkaline phosphatase Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alkaline phosphatase Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alkaline phosphatase Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alkaline phosphatase Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alkaline phosphatase Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Alkaline phosphatase Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoglycemia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoglycemia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoglycemia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoglycemia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoglycemia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hypoglycemia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyperglycemia Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12" } ] } } ] } },{ "OutcomeClassTitle":"Hyperglycemia Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"13" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"13" } ] } } ] } },{ "OutcomeClassTitle":"Hyperglycemia Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"10" } ] } } ] } },{ "OutcomeClassTitle":"Hyperglycemia Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2" } ] } } ] } },{ "OutcomeClassTitle":"Hyperglycemia Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Hyperglycemia Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Participants With Shift of Laboratory Parameters (Creatinine Clearance [Chronic Kidney Disease]) From Baseline Grade to Worst NCI-CTCAE Grade >=3", "OutcomeMeasureDescription":"NCI-CTCAE version 4.03 was used to determine Gr, where Gr refers to severity of AE: Gr 1: mild; asymptomatic/mild symptoms; Gr 2: moderate; minimal; Gr 3: severe/medically significant; Gr 4:life-threatening consequences, Gr 5:death related to AE. Abnormal values for Creatinine Clearance(Chronic kidney disease) were based on: Gr 1: estimated glomerular filtration rate (eGFR) or creatinine clearance (CrCl) = 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years)." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"241" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Creatinine Clearance Gr 0 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine Clearance Gr 1 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine Clearance Gr 2 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine Clearance Gr 3 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine Clearance Gr 4 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Creatinine Clearance Gr 5 at Baseline to Gr >=3", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"AE data was collected from the time of signed informed consent to 30 days following the last administration of study treatment (maximum duration: up to 8 years).", "EventsDescription":"Reported AEs and deaths are TEAEs that developed, worsened, or became serious during the treatment period (time from the first dose of study treatments up to 30 days after last dose of study treatments). Analysis was performed on safety population.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Surgery + Adjuvant Chemotherapy (SC)", "EventGroupDescription":"Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).", "EventGroupDeathsNumAffected":"1", "EventGroupDeathsNumAtRisk":"195", "EventGroupSeriousNumAffected":"57", "EventGroupSeriousNumAtRisk":"195", "EventGroupOtherNumAffected":"141", "EventGroupOtherNumAtRisk":"195" },{ "EventGroupId":"EG001", "EventGroupTitle":"Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC)", "EventGroupDescription":"Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m^2 IV for >= 1 hr on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m^2 IV for >=2 hr on Day 1 of each treatment cycle plus S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 [(Gimeracil) + Oxo (Oteracil)] 40 mg/m^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 8 years).", "EventGroupDeathsNumAffected":"6", "EventGroupDeathsNumAtRisk":"241", "EventGroupSeriousNumAffected":"102", "EventGroupSeriousNumAtRisk":"241", "EventGroupOtherNumAffected":"201", "EventGroupOtherNumAtRisk":"241" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Febrile Neutropenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"23", "SeriousEventStatsNumAffected":"21", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Leukopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Neutropenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Splenic Infarction", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Cataract", "SeriousEventOrganSystem":"Eye disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Abdominal Discomfort", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Abdominal Hernia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Abdominal Pain", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"6", "SeriousEventStatsNumAffected":"6", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"13", "SeriousEventStatsNumAffected":"12", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Ascites", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Colitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Constipation", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Diarrhoea", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"6", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Dysphagia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Enteritis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"7", "SeriousEventStatsNumAffected":"6", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Enterocolitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Gastric Haemorrhage", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"195" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"241" } ] } },{ "SeriousEventTerm":"Haematochezia", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA 22.0", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", 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