{"groups":[{"description":"Participants received intravenous (IV) infusion (minimum 2-hour) of zolbetuximab at a loading dose of 800 milligrams per square meter (mg/m\\^2) on cycle1 day1(C1D1) followed by 600 mg/m\\^2 every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received upto 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4/more cycles. mFOLFOX6 was administered on Days 1, 15 \\& 29 of each cycle (5-FU:400mg/m\\^2 IV bolus over 5-15 minutes followed by 2400mg/m\\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400mg/m\\^2 IV infusion over 2 hours; oxaliplatin: 85mg/m\\^2 IV infusion over 2 hours) A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants continued to receive 5-FU \\& Folinic acid on Days 1, 15 \\& 29 of each cycle at the investigator discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.","id":"FG000","title":"mFOLFOX6 + Zolbetuximab"},{"description":"Participants received an IV infusion (minimum 2-hour infusion) of placebo matched to zolbetuximab on C1D1, followed by subsequent doses every 3 weeks starting from C1D22 until study treatment discontinuation criteria were met. Participants also received up to 12 treatments of mFOLFOX6 (or components if some were discontinued due to toxicity) over 4 or more cycles. mFOLFOX6 was administered on Days 1, 15, and 29 of each cycle (5-fluorouracil: 400 mg/m\\^2 IV bolus over 5-15 minutes followed by 2400mg/m\\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid: 400 mg/m\\^2 IV infusion over 2 hours; oxaliplatin: 85 mg/m\\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15, and 29 of each cycle at the investigator's discretion or until study treatment discontinuation criteria were met. Each cycle was approximately 42 days.","id":"FG001","title":"mFOLFOX6+ Placebo"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"151"},{"groupId":"FG001","numSubjects":"199"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"17"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"16"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"14"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"15"}],"type":"miscellaneous"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}],"type":"Participants who did not take the study drug"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"283"},{"groupId":"FG001","numSubjects":"282"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"279"},{"groupId":"FG001","numSubjects":"278"}],"type":"Participants Who Received at Least One Dose of Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"17"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"257"},{"groupId":"FG001","numSubjects":"265"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. Randomization was stratified by region (Asia vs Non-Asia), number of organs with metastatic sites (0 to 2 vs ≥ 3) and prior gastrectomy (Yes or No).","recruitmentDetails":"Participants with claudin (CLDN)18.2-positive, human epidermal growth factor receptor 2 (HER2) -negative locally advanced unresectable or metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma."}