{"analyses":[{"ciLowerLimit":"0.994","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.687","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0280","pValueComment":"Log-rank test stratified by:\n\n* Region (Asia vs Non-Asia)\n* Number of organs with metastatic sites (0 to 2 vs ≥ 3)\n* Prior gastrectomy (Yes or No)","paramType":"Hazard Ratio (HR)","paramValue":"1.295","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM.","groupId":"OG000","lowerLimit":"6.01","upperLimit":"NA","value":"9.89"},{"comment":"Data was not estimable because less than 50% of participants had event (data was estimated using KM and it requires at least 50% of event to be able to calculate time using KM.","groupId":"OG001","lowerLimit":"9.26","upperLimit":"NA","value":"12.32"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"283"},{"groupId":"OG001","value":"282"}],"units":"Participants"}],"description":"TTCD: time from randomization to first clinically meaning full deterioration (CMD) that was confirmed at next scheduled visit. EORTC-QLQ-C30 was a 30-item cancer-specific instrument consisting of 5 functional scales (physical,role,emotional,social \\& cognitive), 9 symptom scales (fatigue, nausea/vomiting,general pain,dyspnea,insomnia,appetite loss,constipation,diarrhea,financial difficulties) \\& global health status scale. Most items were scored 1(not at all) to 4(very much) except for items contributing to global health status/QoL, which were scored 1(very poor) to 7(excellent). All raw domain scores were linearly transformed to 0-100scale with higher scores on symptoms indicate worse health state. CMD was defined if a participant's change from baseline exceeded a pre-specified threshold of -13. This was derived from an Exit Survey conducted using Patient Global Impression of Severity/Change(PGIS/PGIC) questionnaires as an anchor for estimating meaningful change. KM estimates was used.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\\^2 on C1D1 followed by subsequent doses of 600 mg/m\\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\\^2 over 5 to 15 minutes followed by 2400mg/m\\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\\^2 IV infusion over 2 hours; oxaliplatin administered 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 the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.","id":"OG000","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":"OG001","title":"mFOLFOX6+ Placebo"}],"paramType":"MEDIAN","populationDescription":"FAS","reportingStatus":"POSTED","timeFrame":"From the date of randomization until 62 months and 18 days","title":"Time to Confirmed Deterioration (TTCD) Using Physical Functioning (PF) as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30)","type":"SECONDARY","unitOfMeasure":"Months"}