{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"232","value":"211"}]}],"title":"Cmax (Cycle 1 Day 1, 1 hour post-dose) (n=128)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"29.8","value":"57.9"}]}],"title":"Ctrough (Cycle 4 Day 1, pre-dose) (n=46)"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"362","value":"308"}]}],"title":"Cmax (Cycle 4 Day 1, 1 hour post-dose) (n=37)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"163"}],"units":"Participants"}],"description":"Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations).","dispersionType":"Standard Deviation","groups":[{"description":"Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\\^2 (for a total cycle dose of 1.5 mg/m\\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).","id":"OG000","title":"Inotuzumab Ozogamicin"}],"paramType":"MEAN","populationDescription":"Pharmacokinetic (PK) evaluable population - included all participants with available PK data.","reportingStatus":"POSTED","timeFrame":"Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4","title":"Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing","type":"SECONDARY","unitOfMeasure":"ng/mL"}