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calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"0.00","value":"0.0"}]}],"title":"Diarrhoea: 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":"6.67","value":"6.7"}]}],"title":"Diarrhoea: 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":"0.00","value":"0.0"}]}],"title":"Diarrhoea: 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 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(n=45,111)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.76","value":"15.6"},{"groupId":"OG001","spread":"2.89","value":"23.4"}]}],"title":"Financial Difficulties: Week 31 (n=45,94)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.92","value":"10.2"},{"groupId":"OG001","spread":"2.96","value":"24.5"}]}],"title":"Financial Difficulties: Week 34 (n=36,87)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"4.83","value":"13.8"},{"groupId":"OG001","spread":"3.38","value":"23.4"}]}],"title":"Financial Difficulties: Week 37 (n=29,64)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"5.18","value":"22.2"},{"groupId":"OG001","spread":"3.74","value":"23.6"}]}],"title":"Financial Difficulties: Week 40 (n=24,55)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"7.68","value":"16.7"},{"groupId":"OG001","spread":"3.72","value":"19.4"}]}],"title":"Financial Difficulties: Week 43 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(n=3,12)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.11","value":"11.1"},{"groupId":"OG001","spread":"8.33","value":"25.0"}]}],"title":"Financial Difficulties: Week 76 (n=3,8)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"11.11","value":"11.1"},{"groupId":"OG001","spread":"10.80","value":"25.9"}]}],"title":"Financial Difficulties: Week 79 (n=3,9)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.67","value":"16.7"},{"groupId":"OG001","spread":"7.03","value":"22.2"}]}],"title":"Financial Difficulties: Week 82 (n=2,6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.67","value":"16.7"},{"groupId":"OG001","spread":"7.45","value":"16.7"}]}],"title":"Financial Difficulties: Week 85 (n=2,6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.67","value":"16.7"},{"groupId":"OG001","spread":"7.45","value":"16.7"}]}],"title":"Financial Difficulties: Week 88 (n=2,6)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.67","value":"16.7"},{"groupId":"OG001","spread":"8.33","value":"25.0"}]}],"title":"Financial Difficulties: Week 91 (n=2,4)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"16.67","value":"16.7"},{"groupId":"OG001","spread":"7.45","value":"16.7"}]}],"title":"Financial Difficulties: 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":"8.16","value":"20.0"}]}],"title":"Financial Difficulties: 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 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be calculated.","groupId":"OG000","spread":"NA","value":"0.0"},{"groupId":"OG001","spread":"9.62","value":"16.7"}]}],"title":"Financial Difficulties: 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":"8.16","value":"13.3"}]}],"title":"Financial Difficulties: 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":"9.62","value":"16.7"}]}],"title":"Financial Difficulties: 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":"8.16","value":"13.3"}]}],"title":"Financial Difficulties: 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":"8.16","value":"13.3"}]}],"title":"Financial Difficulties: 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":"8.16","value":"13.3"}]}],"title":"Financial Difficulties: Week 124 (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":"11.11","value":"11.1"}]}],"title":"Financial Difficulties: Week 127 (n=1,3)"},{"categories":[{"measurements":[{"comment":"No participants were analyzed in this treatment group at this timepoint.","groupId":"OG000","spread":"NA","value":"NA"},{"groupId":"OG001","spread":"11.11","value":"11.1"}]}],"title":"Financial Difficulties: 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":"0.00","value":"0.0"}]}],"title":"Financial Difficulties: Week 133 (n=1,3)"},{"categories":[{"measurements":[{"comment":"No participants were analyzed in this treatment group at this 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be calculated.","groupId":"OG001","spread":"NA","value":"0.0"}]}],"title":"Financial Difficulties: Week 145 (n=0,1)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.39","value":"26.6"},{"groupId":"OG001","spread":"2.51","value":"27.9"}]}],"title":"Financial Difficulties: Final Visit (n=158,160)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"290"},{"groupId":"OG001","value":"294"}],"units":"Participants"}],"description":"EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.","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) = 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":"European Organisation For the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ C-30) Questionnaire Scores","type":"SECONDARY","unitOfMeasure":"scores on a scale"}