{"analyses":[{"groupDescription":"Comparison of Global Health Status","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6388","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Global Health Status","groupIds":["OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8445","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Physical Functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6388","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Physical Functioning","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9435","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Role functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2654","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Role functioning","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7674","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Emotional Functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1628","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Emotional Functioning","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Cognitive Functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7738","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Cognitive Functioning","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Social Functioning","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3408","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Social Functioning","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Fatigue","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6766","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Fatigue","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Nausea and Vomiting","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6388","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Nausea and Vomiting","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7674","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Pain","groupIds":["OG000","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.4993","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Pain","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Dyspnoea","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.2654","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Dyspnoea","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Insomnia","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7617","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Insomnia","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Appetite loss","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9123","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Appetite loss","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Constipation","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7617","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Constipation","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Diarrhoea","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1628","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Diarrhoea","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6712","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Financial difficulties","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6388","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false},{"groupDescription":"Comparison of Financial difficulties","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7308","pValueComment":"For each experimental arm comparison p-values were adjusted for multiple domain comparisons using the Hochberg method.","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"17"},{"groupId":"OG003","value":"12"}]}],"title":"Global Health Status: Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"41"},{"groupId":"OG002","value":"38"},{"groupId":"OG003","value":"44"}]}],"title":"Global Health Status: Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"45"},{"groupId":"OG003","value":"44"}]}],"title":"Global Health Status: Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"11"}]}],"title":"Physical Functioning: Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"40"}]}],"title":"Physical Functioning: Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"49"},{"groupId":"OG003","value":"49"}]}],"title":"Physical Functioning: Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"15"},{"groupId":"OG003","value":"11"}]}],"title":"Role Functioning: Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"37"}]}],"title":"Role Functioning: Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"52"},{"groupId":"OG003","value":"53"}]}],"title":"Role Functioning: Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"9"}]}],"title":"Emotional Functioning:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"46"},{"groupId":"OG003","value":"58"}]}],"title":"Emotional Functioning:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"56"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"33"}]}],"title":"Emotional Functioning:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"7"}]}],"title":"Cognitive Functioning:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"32"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"44"}]}],"title":"Cognitive Functioning:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"54"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"49"}]}],"title":"Cognitive Functioning:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"11"}]}],"title":"Social Functioning:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"47"}]}],"title":"Social Functioning:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"62"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"54"},{"groupId":"OG003","value":"42"}]}],"title":"Social Functioning:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"12"}]}],"title":"Fatigue:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"33"}]}],"title":"Fatigue:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"69"},{"groupId":"OG001","value":"59"},{"groupId":"OG002","value":"66"},{"groupId":"OG003","value":"54"}]}],"title":"Fatigue:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"4"}]}],"title":"Nausea and Vomiting:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"32"},{"groupId":"OG003","value":"46"}]}],"title":"Nausea and Vomiting:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"58"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"51"}]}],"title":"Nausea and Vomiting:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"27"},{"groupId":"OG003","value":"11"}]}],"title":"Pain:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"37"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"40"}]}],"title":"Pain:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"39"},{"groupId":"OG003","value":"49"}]}],"title":"Pain:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"5"}]}],"title":"Dyspnoea:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"69"},{"groupId":"OG002","value":"51"},{"groupId":"OG003","value":"68"}]}],"title":"Dyspnoea:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"42"},{"groupId":"OG003","value":"25"}]}],"title":"Dyspnoea:Worsoned"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"18"},{"groupId":"OG003","value":"5"}]}],"title":"Insomnia:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"49"},{"groupId":"OG002","value":"34"},{"groupId":"OG003","value":"49"}]}],"title":"Insomnia:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"48"},{"groupId":"OG003","value":"46"}]}],"title":"Insomnia:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"11"},{"groupId":"OG003","value":"5"}]}],"title":"Appetite Loss:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"42"},{"groupId":"OG002","value":"45"},{"groupId":"OG003","value":"46"}]}],"title":"Appetite Loss:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"52"},{"groupId":"OG002","value":"44"},{"groupId":"OG003","value":"49"}]}],"title":"Appetite Loss:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"4"}]}],"title":"Constipation:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"47"},{"groupId":"OG001","value":"63"},{"groupId":"OG002","value":"56"},{"groupId":"OG003","value":"67"}]}],"title":"Constipation:Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"34"},{"groupId":"OG002","value":"31"},{"groupId":"OG003","value":"30"}]}],"title":"Constipation:Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"4"}]}],"title":"Diarrhoea:Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"39"},{"groupId":"OG003","value":"58"}]}],"title":"Diarrhoea: Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"39"},{"groupId":"OG002","value":"55"},{"groupId":"OG003","value":"39"}]}],"title":"Diarrhoea: Worsened"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"0"}]}],"title":"Financial Difficulties: Improved"},{"categories":[{"measurements":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"67"},{"groupId":"OG002","value":"51"},{"groupId":"OG003","value":"74"}]}],"title":"Financial Difficulties: Stable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"42"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"41"},{"groupId":"OG003","value":"26"}]}],"title":"Financial Difficulties: Worsened"}],"denoms":[{"counts":[{"groupId":"OG000","value":"105"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"71"},{"groupId":"OG003","value":"57"}],"units":"Participants"}],"description":"This patient recorded outcome consists of 15 subscales in 3 independent domains: global health-related quality of life (HRQoL), functional scales (cognitive, emotional, physical, role and social functioning), and symptom scales (appetite loss, constipation, diarrhea, dyspnea, fatigue, insomnia, nausea and vomiting, and pain). For each subscale, patients were classified as improved, worsened or stable. Improvement is indicated by achievement of subscale score at least 10% improved from baseline and maintained for at least 6 weeks. Worsened is indicated by subscale score at least 10% worse than baseline. Stable is indicated by neither improvement nor worsened. Achievement of improvement prior to worsening was classified as improvement.","groups":[{"description":"• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1\\*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.","id":"OG000","title":"MM-398 Arm A (Mono Therapy Comparison)"},{"description":"* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle\n* Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.","id":"OG001","title":"5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)"},{"description":"* MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1\\*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.\n* 5-FU 2400 mg/m2 IV over 46-hours, and\n* Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks","id":"OG002","title":"MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison"},{"description":"* 5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle\n* Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle.","id":"OG003","title":"5-FU + Leucovorin (Combo Therapy Comparison)"}],"paramType":"NUMBER","populationDescription":"ITT patients who had baseline and at least one-post baseline EORTC-QLQ-C30 assessment.","reportingStatus":"POSTED","timeFrame":"Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months","title":"EORTC-QLQ-C30","type":"SECONDARY","unitOfMeasure":"percent of patients in category"}