{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"197.4","value":"2550.00"},{"groupId":"OG001","spread":"209.7","value":"2120.00"}]}],"title":"Total Irinotecan-Cavg"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"172.3","value":"40550.00"},{"groupId":"OG001","spread":"69.3","value":"28460.00"}]}],"title":"Total Irinotecan-Cmax"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"119.2","value":"0.82"},{"groupId":"OG001","spread":"132.7","value":"0.68"}]}],"title":"Total SN38-Cavg"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"119.6","value":"3.93"},{"groupId":"OG001","spread":"121.9","value":"2.58"}]}],"title":"Total SN38-Cmax"}],"denoms":[{"counts":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"114"}],"units":"Participants"}],"description":"Plasma concentration-time data for MM-398 will be analyzed using population pharmacokinetic methods.","dispersionType":"Geometric Coefficient of Variation","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":"* 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":"OG001","title":"MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK population was based on Protocol, all participants who received the appropriate dose of MM-398.","reportingStatus":"POSTED","timeFrame":"6 weeks after first study drug administration","title":"Pharmacokinetic Measurements of Total Irinotecan","type":"SECONDARY","unitOfMeasure":"Total irinotecan = ug/L; SN38= ug/L"}