{"analyses":[{"ciLowerLimit":"0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.03","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.1008","paramType":"Hazard Ratio (HR)","paramValue":"0.82","statisticalComment":"Unstratified log rank test.","statisticalMethod":"Log Rank","testedNonInferiority":false},{"ciLowerLimit":"0.45","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.78","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0002","paramType":"Hazard Ratio (HR)","paramValue":"0.60","statisticalComment":"Unstratified log rank test","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.5","upperLimit":"2.7","value":"1.7"},{"groupId":"OG001","lowerLimit":"1.3","upperLimit":"1.4","value":"1.4"},{"groupId":"OG002","lowerLimit":"1.6","upperLimit":"2.8","value":"2.3"},{"groupId":"OG003","lowerLimit":"1.3","upperLimit":"1.4","value":"1.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"149"},{"groupId":"OG002","value":"117"},{"groupId":"OG003","value":"119"}],"units":"Participants"}],"description":"Time from randomization to discontinuation of treatment for any reason, including disease progression, treatment toxicity or death.","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"ITT Population","reportingStatus":"POSTED","timeFrame":"Randomization to treatment discontinuation (any cause). The maximum time in follow up was 25 months","title":"Time to Treatment Failure","type":"SECONDARY","unitOfMeasure":"months"}