{"analyses":[{"ciLowerLimit":"2.4","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"16.9","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0081","paramType":"Difference in Clinical Benefit Rate","paramValue":"9.60","statisticalMethod":"Chi-squared","testedNonInferiority":false},{"ciLowerLimit":"1.14","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.41","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Odds Ratio (OR)","paramValue":"1.66","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"63.7","upperLimit":"74.6","value":"69.3"},{"groupId":"OG001","lowerLimit":"73.8","upperLimit":"83.4","value":"78.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"294"}],"units":"Participants"}],"description":"Clinical benefit was defined as stable disease (SD), CR, or PR for 6 weeks or longer as determined by RECIST. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as a reference the smallest SLD recorded since treatment had started. For NTLs, SD was defined as a persistence of one or more NTLs and/or maintenance of tumor marker levels above the normal limits.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m\\^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m\\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\\^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.","id":"OG000","title":"Fluoropyrimidine/Cisplatin (FP)"},{"description":"Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator's discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m\\^2 IV on Day 1; and EITHER 5-FU 800 mg/m\\^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m\\^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.","id":"OG001","title":"Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)"}],"paramType":"NUMBER","populationDescription":"FAS","reportingStatus":"POSTED","timeFrame":"BL, Days 43, 85, and 127, and every 21 days thereafter until disease progression or the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis","title":"Percentage of Participants With Clinical Benefit","type":"SECONDARY","unitOfMeasure":"percentage of participants"}