{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"55"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"55"}],"units":"Participants"}],"description":"Overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse).","groups":[{"description":"Patients receive 8 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.","id":"OG000","title":"Arm 1 (mFOLFIRINOX + Surgery + FOLFOX)"},{"description":"Patients receive 7 cycles of mFOLFIRINOX. One cycle is 14 days. mFOLFIRINOX consists of oxaliplatin, irinotecan, leucovorin and 5-FU. Patients receive radiation therapy then undergo surgery and receive 4 cycles of FOLFOX 4-12 weeks after surgery. FOLFOX consists of oxaliplatin, leucovorin and 5-FU.","id":"OG001","title":"Arm 2 (mFOLFIRINOX + Radiation + Surgery + FOLFOXx)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"All patients that were treated and assessed for adverse events","reportingStatus":"POSTED","timeFrame":"1 year","title":"Incidence of Adverse Events Assessed Per Common Terminology Criteria for Adverse Events (CTCAE) Version 4 and the Patient-Reported Outcomes Version of the CTCAE","type":"SECONDARY","unitOfMeasure":"Participants"}