{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.42","value":"21.1"},{"groupId":"OG001","spread":"1.25","value":"17.9"}]}],"title":"BL (n=275,284)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.17","value":"14.6"},{"groupId":"OG001","spread":"1.11","value":"13.3"}]}],"title":"Week 4 (n=234,249)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.15","value":"11.1"},{"groupId":"OG001","spread":"1.31","value":"13.8"}]}],"title":"Week 7 (n=181,219)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.46","value":"14.5"},{"groupId":"OG001","spread":"1.30","value":"12.9"}]}],"title":"Week 10 (n=174, 202)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.37","value":"11.3"},{"groupId":"OG001","spread":"1.35","value":"12.2"}]}],"title":"Week 13 (n=152,181)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.77","value":"14.0"},{"groupId":"OG001","spread":"1.53","value":"12.8"}]}],"title":"Week 16 (n=121,165)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.92","value":"15.4"},{"groupId":"OG001","spread":"1.43","value":"12.0"}]}],"title":"Week 19 (n=114,142)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.20","value":"13.3"},{"groupId":"OG001","spread":"1.81","value":"15.1"}]}],"title":"Week 22 (n=79,141)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.39","value":"12.7"},{"groupId":"OG001","spread":"1.50","value":"11.0"}]}],"title":"Week 25 (n=64,124)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.85","value":"8.6"},{"groupId":"OG001","spread":"1.80","value":"12.3"}]}],"title":"Week 28 (n=47,111)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.11","value":"8.7"},{"groupId":"OG001","spread":"1.92","value":"12.5"}]}],"title":"Week 31 (n=45,95)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.90","value":"9.4"},{"groupId":"OG001","spread":"1.79","value":"10.7"}]}],"title":"Week 34 (n=37,86)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.08","value":"15.5"},{"groupId":"OG001","spread":"2.22","value":"10.9"}]}],"title":"Week 37 (n=29,64)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.20","value":"16.4"},{"groupId":"OG001","spread":"1.99","value":"8.8"}]}],"title":"Week 40 (n=24,54)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.04","value":"12.6"},{"groupId":"OG001","spread":"2.15","value":"7.2"}]}],"title":"Week 43 (n=12,43)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.11","value":"16.1"},{"groupId":"OG001","spread":"2.30","value":"7.4"}]}],"title":"Week 46 (n=14,41)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.71","value":"7.2"},{"groupId":"OG001","spread":"2.09","value":"6.5"}]}],"title":"Week 49 (n=10,36)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.43","value":"5.8"},{"groupId":"OG001","spread":"2.75","value":"6.9"}]}],"title":"Week 52 (n=8,30)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.20","value":"2.3"},{"groupId":"OG001","spread":"1.48","value":"3.3"}]}],"title":"Week 55 (n=6,24)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.20","value":"4.7"},{"groupId":"OG001","spread":"1.91","value":"3.8"}]}],"title":"Week 58 (n=6,20)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.04","value":"5.3"},{"groupId":"OG001","spread":"5.03","value":"7.2"}]}],"title":"Week 61 (n=4,17)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.00","value":"2.0"},{"groupId":"OG001","spread":"3.14","value":"6.8"}]}],"title":"Week 64 (n=3,20)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.96","value":"1.5"},{"groupId":"OG001","spread":"5.04","value":"8.9"}]}],"title":"Week 67 (n=4,17)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.33","value":"1.3"},{"groupId":"OG001","spread":"1.15","value":"1.3"}]}],"title":"Week 70 (n=3,13)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.58","value":"1.0"},{"groupId":"OG001","spread":"8.30","value":"16.5"}]}],"title":"Week 73 (n=3,10)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.88","value":"1.7"},{"groupId":"OG001","spread":"11.12","value":"12.9"}]}],"title":"Week 76 (n=3,8)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.58","value":"1.0"},{"groupId":"OG001","spread":"3.89","value":"5.9"}]}],"title":"Week 79 (n=3,9)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.00","value":"0.0"},{"groupId":"OG001","spread":"4.83","value":"4.8"}]}],"title":"Week 82 (n=2,6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.00","value":"1.0"},{"groupId":"OG001","spread":"6.14","value":"6.3"}]}],"title":"Week 85 (n=2,6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.50","value":"0.5"},{"groupId":"OG001","spread":"5.47","value":"5.7"}]}],"title":"Week 88 (n=2,6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.50","value":"0.5"},{"groupId":"OG001","spread":"6.85","value":"7.5"}]}],"title":"Week 91 (n=2,4)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.50","value":"0.5"},{"groupId":"OG001","spread":"5.83","value":"5.8"}]}],"title":"Week 94 (n=2,6)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"0.20","value":"0.2"}]}],"title":"Week 97 (n=1,5)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":".25","value":"0.3"}]}],"title":"Week 100 (n=1,4)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"5.85","value":"6.5"}]}],"title":"Week 103 (n=1,4)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"6.79","value":"7.8"}]}],"title":"Week 106 (n=1,4)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"7.25","value":"7.3"}]}],"title":"Week 109 (n=1,4)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"3.50","value":"4.2"}]}],"title":"Week 112 (n=1,5)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"5.11","value":"5.8"}]}],"title":"Week 115 (n=1,4)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"3.32","value":"3.8"}]}],"title":"Week 118 (n=1,5)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"3.20","value":"3.2"}]}],"title":"Week 121 (n=1,5)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"3.84","value":"4.5"}]}],"title":"Week 124 (n=1,4)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"6.33","value":"6.3"}]}],"title":"Week 127 (n=1,3)"},{"categories":[{"measurements":[{"comment":"No participants were analyzed in this treatment group for this timepoint.","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"5.67","value":"5.7"}]}],"title":"Week 130 (n=0,3)"},{"categories":[{"measurements":[{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"5.00","value":"5.0"}]}],"title":"Week 133 (n=1,3)"},{"categories":[{"measurements":[{"comment":"No participants were analyzed in this treatment group for this timepoint.","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"6.00","value":"6.0"}]}],"title":"Week 136 (n=0,2)"},{"categories":[{"measurements":[{"comment":"No participants were analyzed in this treatment group for this timepoint.","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"8.00","value":"8.0"}]}],"title":"Week 139 (n=0,2)"},{"categories":[{"measurements":[{"comment":"No participants were analyzed in this treatment group for this timepoint.","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"7.50","value":"7.5"}]}],"title":"Week 142 (n=0,2)"},{"categories":[{"measurements":[{"comment":"No participants were analyzed in this treatment group for this timepoint.","groupId":"OG000","spread":"NA","value":"NA"},{"comment":"Only 1 participant was analyzed in this treatment group at this timepoint, therefore standard error of the mean could not be calculated.","groupId":"OG001","spread":"NA","value":"15.0"}]}],"title":"Week 145 (n=0,1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.99","value":"23.8"},{"groupId":"OG001","spread":"2.18","value":"21.9"}]}],"title":"Final visit/withdrawal (n=157,161)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"294"}],"units":"Participants"}],"description":"The participant assessed their pain on a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as \"no pain\" and the right-hand extreme equals 100 mm as \"unbearable pain\". A negative change indicated improvement.","dispersionType":"Standard Error","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":"MEAN","populationDescription":"FAS; n = number of participants assessed for a specific parameter at a given visit.","reportingStatus":"POSTED","timeFrame":"BL, Days 1, 22, 43, 64, 85, 106, 127, and every 21 days until disease progression of the end of study, 1 year after the cut-off date for the 2nd interim efficacy analysis","title":"Pain Intensity Scores as Assessed By Visual Analog Scale (VAS)","type":"SECONDARY","unitOfMeasure":"mm"}