{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.22","upperLimit":"4.02","value":"2.62"},{"groupId":"OG001","lowerLimit":"2.61","upperLimit":"3.39","value":"3.08"},{"groupId":"OG002","lowerLimit":"0.0328","upperLimit":"6.15","value":"3.09"},{"groupId":"OG003","lowerLimit":"1.20","upperLimit":"2.66","value":"1.93"},{"groupId":"OG004","lowerLimit":"1.99","upperLimit":"25.0","value":"12.4"},{"groupId":"OG005","lowerLimit":"1.73","upperLimit":"21.8","value":"3.63"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"11"}],"units":"Participants"}],"description":"The AUC accumulation ratio of moxetumomab pasudotox was calculated as the geometric mean ratio of AUC(0-last) on the last day and the first day of a multiple dose regimen: Day 5/Day 1.","dispersionType":"Full Range","groups":[{"description":"Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.","id":"OG000","title":"5 mcg/kg"},{"description":"Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.","id":"OG001","title":"10 mcg/kg"},{"description":"Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.","id":"OG002","title":"20 mcg/kg"},{"description":"Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.","id":"OG003","title":"30 mcg/kg"},{"description":"Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.","id":"OG004","title":"40 mcg/kg"},{"description":"Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.","id":"OG005","title":"50 mcg/kg"}],"paramType":"MEDIAN","populationDescription":"The PK Population consisted of all participants who received any amount of moxetumomab pasudotox and had a sufficient number of serum concentration measurements for computing PK parameters. The \"Overall Number of Participants Analyzed\" denotes the number of participants evaluated for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 1 and Day 5: pre-infusion, at 15 min during the infusion, at the end of infusion, and at 1, 1.5, 2, 4, 8, and 12 h post infusion","title":"AUC Accumulation Ratio of Moxetumomab Pasudotox for Cycle 1","type":"PRIMARY","unitOfMeasure":"ratio"}