{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.024","statisticalMethod":"Fisher Exact","testedNonInferiority":false},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","statisticalMethod":"Fisher Exact","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.6"},{"groupId":"OG001","value":"11.4"},{"groupId":"OG002","value":"28.9"},{"groupId":"OG003","value":"8.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"105"},{"groupId":"OG002","value":"97"},{"groupId":"OG003","value":"81"}],"units":"Participants"}],"description":"Tumor marker response (TMR) was evaluated by the change in CA19-9 serum levels. Response was defined as a decrease of 50% of CA19-9 in relation to the baseline level at least once during the treatment period.","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":"Patients with elevated baseline CA19-9 value (\\> 30 U/mL) who received study drug.","reportingStatus":"POSTED","timeFrame":"Baseline to treatment discontinuation every 6 weeks; The maximum time in follow up was 25 months","title":"Percentage of Patients With Tumor Marker (CA 19-9) Response","type":"SECONDARY","unitOfMeasure":"percent of participants with TMR"}