{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"53.09","value":"6.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"79"}],"units":"Participants"}],"title":"Cycle 1 Day 1 (Predose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"53724.93","value":"249075.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"}],"units":"Participants"}],"title":"Cycle 1 Day 1 (1 hour post dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"39105.37","value":"126306.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"}],"units":"Participants"}],"title":"Cycle 1 Day 4 (pre-dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"82971.54","value":"363626.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"}],"units":"Participants"}],"title":"Cycle 1 Day 4 (1 hour post-dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"50655.86","value":"157722.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"}],"units":"Participants"}],"title":"Cycle 1 Day 15 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"97215.09","value":"396262.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"}],"units":"Participants"}],"title":"Cycle 1 Day 15 (1 hour post-dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"72582.62","value":"181870.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"}],"units":"Participants"}],"title":"Cycle 2 Day 1 (predose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"126930.55","value":"439788.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"62"}],"units":"Participants"}],"title":"Cycle 2 Day 1 (1 hour post-dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"77799.93","value":"217846.9"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"63"}],"units":"Participants"}],"title":"Cycle 2 Day 15 (Pre Dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"85475.90","value":"442940.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"}],"units":"Participants"}],"title":"Cycle 2 Day 15 (1 hour post-dose) )"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"68866.46","value":"208520.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"61"}],"units":"Participants"}],"title":"Cycle 3 Day 1 (predose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"112647.31","value":"466135.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"53"}],"units":"Participants"}],"title":"Cycle 3 Day 1 (1 hour post-dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"85170.91","value":"223909.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"}],"units":"Participants"}],"title":"Cycle 3 Day 15 (predose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"104198.64","value":"455635.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"44"}],"units":"Participants"}],"title":"Cycle 3 Day 15 (1 hour post-dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"94553.25","value":"216328.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"}],"units":"Participants"}],"title":"Cycle 4 Day 1 (predose) )"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"72691.16","value":"142134.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"}],"units":"Participants"}],"title":"Cycle 5 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"55774.77","value":"115132.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"}],"units":"Participants"}],"title":"Cycle 6 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"73328.15","value":"114661.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"}],"units":"Participants"}],"title":"Cycle 7 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"52282.72","value":"108640.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"40"}],"units":"Participants"}],"title":"Cycle 9 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"64872.47","value":"126472.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"34"}],"units":"Participants"}],"title":"Cycle 11 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"61229.42","value":"100853.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"}],"units":"Participants"}],"title":"Cycle 13 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"61199.32","value":"159676.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"}],"units":"Participants"}],"title":"Cycle 15 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"64592.17","value":"175855.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"}],"units":"Participants"}],"title":"Cycle 17 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"69962.05","value":"197045.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"}],"units":"Participants"}],"title":"Cycle 19 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"53222.03","value":"197228.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"}],"units":"Participants"}],"title":"Cycle 21 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"64686.85","value":"224253.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"}],"units":"Participants"}],"title":"Cycle 23 Day 1 (pre dose)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"114804.40","value":"141240.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"}],"units":"Participants"}],"title":"End of Treatment"}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"}],"units":"Participants"}],"description":"The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling.\n\nMOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).","dispersionType":"Standard Deviation","groups":[{"description":"MOR00208:\n\nMOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.\n\nAdditionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.\n\nLEN:\n\nParticipants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.\n\nOn days when both study drugs were given together, LEN was administered prior to MOR00208.","id":"OG000","title":"Tafasitamab (MOR00208) + Lenalidomide (LEN)"}],"paramType":"MEAN","populationDescription":"PK analysis set (PKAS): The PKAS included all participants who received at least one dose of MOR00208 and had at least one quantifiable MOR00208 serum concentration.\n\nNumber analyzed includes only participants with data at each timepoint.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment","title":"Serum Drug Levels of MOR00208","type":"SECONDARY","unitOfMeasure":"ng/mL"}