{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.82","statisticalMethod":"Fisher Exact","testedNonInferiority":false},{"groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.80","statisticalMethod":"Fisher Exact","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"80"},{"groupId":"OG002","value":"78"},{"groupId":"OG003","value":"60"}],"units":"Participants"}],"description":"Composite measure based on patient-reported pain (per VAS), patient-reported pain medication, KPS, and weight. Clinical benefit is indicated by either:\n\n(a) improvement in pain (less pain intensity with stable or decreased pain medication; or less pain medication with stable or decreased pain intensity) with stable or improved KPS; or (b) improvement in KPS with stable or improved pain.\n\nWith stable for KPS and pain, clinical benefit may be indicated with an observation of positive weight change.\n\nClinical benefit response (CBR) was classified weekly and a patient was considered a clinical benefit responder if clinical benefit was observed and maintained over a 4 week 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":"Clinical Benefit Response Evaluable Population: Patients who received study drug and met at least one of the following criteria were defined as eligible for evaluation of CBR:\n\n* baseline pain intensity ≥ 20 (out of 100)\n* baseline morphine consumption ≥ 10 mg/day PO morphine equivalents\n* baseline KPS of 70 to 90 points","reportingStatus":"POSTED","timeFrame":"Randomization to treatment discontinuation.The maximum time in follow up was 25 months","title":"Percentage of Patients With Clinical Benefit Response","type":"SECONDARY","unitOfMeasure":"percentage of participants with CBR"}