{"analyses":[{"ciLowerLimit":"0.77","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.28","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9416","paramType":"Hazard Ratio (HR)","paramValue":"0.99","statisticalComment":"Unstratified logrank test.","statisticalMethod":"Log Rank","testedNonInferiority":false},{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.92","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.012","paramType":"Hazard Ratio (HR)","paramValue":"0.67","statisticalComment":"Unstratified logrank test.","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.23","upperLimit":"5.62","value":"4.9"},{"groupId":"OG001","lowerLimit":"3.58","upperLimit":"4.86","value":"4.2"},{"groupId":"OG002","lowerLimit":"4.76","upperLimit":"8.87","value":"6.1"},{"groupId":"OG003","lowerLimit":"3.29","upperLimit":"5.32","value":"4.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"151"},{"groupId":"OG001","value":"149"},{"groupId":"OG002","value":"117"},{"groupId":"OG003","value":"119"}],"units":"Participants"}],"description":"Overall survival was the primary efficacy endpoint of the study and was defined as the time from the date of patient randomization to the date of death or the date the patient was last known to be alive. OS was summarized by Kaplan-Meier methodology for each treatment group. Pairwise treatment group comparisons were carried out using unstratified log rank analyses on the ITT population. Hazard ratio estimates are from Cox regression analysis.\n\nThe comparison of Arm C is based only on patients who were randomized under the 3-arm version of the protocol. Consequently, the 5-FU+Leucovorin (Combo Therapy Comparison) group is a subset of all patients randomized to 5-FU+Leucovorin, which is the Mono Therapy Comparison control and contains patients randomized under both the 2-arm and 3-arm versions of the protocol.","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":"Intent to Treat population (ITT population) consisted of all randomized participants. Efficacy analyses in the ITT population consider treatment group according to randomization. Comparisons of the MM-398+5-FU/LV to 5-FU/LV were carried out only on patients who were randomized under protocol version 2 or later.","reportingStatus":"POSTED","timeFrame":"From randomization to death; until the data cut off 14 Feb 2014. The maximum time in follow up was 25 months.","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"months"}