{"classes":[{"categories":[{"measurements":[{"comment":"The standard deviation was not estimable for a single participant.","groupId":"OG001","spread":"NA","value":"550"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 1"},{"categories":[{"measurements":[{"groupId":"OG002","spread":"27.6","value":"1200"},{"groupId":"OG003","spread":"400","value":"1610"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"}],"units":"Participants"}],"title":"Cycle 1 Day 8"},{"categories":[{"measurements":[{"groupId":"OG004","spread":"948","value":"1230"},{"groupId":"OG005","spread":"304","value":"1130"},{"groupId":"OG006","spread":"519","value":"1350"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"56"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"10"}],"units":"Participants"}],"title":"Cycle 1 Day 15"},{"categories":[{"measurements":[{"groupId":"OG003","spread":"595","value":"985"},{"groupId":"OG004","spread":"2210","value":"1440"},{"comment":"The standard deviation was not estimable for a single participant.","groupId":"OG005","spread":"NA","value":"1100"},{"groupId":"OG006","spread":"1820","value":"2340"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"16"},{"groupId":"OG005","value":"1"},{"groupId":"OG006","value":"2"}],"units":"Participants"}],"title":"Cycle 2 Day 1"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"56"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"10"}],"units":"Participants"}],"description":"CL of TAK-186 was reported. As prespecified in the analysis plan, all participants in this combined cohort received the same target dose level of TAK-186. Therefore, data from these participants were pooled and analyzed as a single cohort.","dispersionType":"Standard Deviation","groups":[{"description":"Participants received TAK-186, Dose A as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose A is the lowest dose.","id":"OG000","title":"Dose Escalation Phase: TAK-186 - Dose A + Dexamethasone"},{"description":"Participants received TAK-186, Dose B as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose B is higher than Dose A.","id":"OG001","title":"Dose Escalation Phase: TAK-186 -Dose B + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose C is higher than Dose B.","id":"OG002","title":"Dose Escalation Phase: TAK-186 -Dose B → Dose C + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose D on Day 8 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose D is higher than Dose B.","id":"OG003","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose D + Dexamethasone"},{"description":"Participants in Dose Escalation Phase and Cohort Expansion Phase received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose E on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion and post-infusion. Dose E is higher than Dose C and B.","id":"OG004","title":"Dose Escalation Phase and Cohort Expansion Phase: TAK-186 - Dose B → Dose C→ Dose E + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose F on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone was administered pre-infusion. Dose F is highest dose and is higher than Dose B and C.","id":"OG005","title":"Dose Escalation Phase: TAK-186 - Dose B→ Dose C→ Dose F + Dexamethasone"},{"description":"Participants received TAK-186, Dose B on Day 1 followed by Dose C on Day 8 and Dose D on Day 15 and thereafter as an IV infusion, QW until PD, completion of 7 cycles in the event of no radiologic evidence of tumor regression, withdrawal of consent, or death. Dexamethasone premedication was administered pre-infusion and post-infusion. Dose D is higher than Dose B and C.","id":"OG006","title":"Dose Escalation Phase: TAK-186 - Dose B → Dose C→ Dose D + Dexamethasone"}],"paramType":"MEAN","populationDescription":"PK population. \"Overall Number of Participants Analyzed\" signifies participants evaluable for this outcome measure \\& \"number analyzed\" signifies participants at specific categories. No participants in Dose Escalation Phase: TAK-186 - Dose A Arm group attended for the CL. TAK-186 was administered QW and had a LiD regimen including 1-step and 2-step lead-in. Analysis at the lead-in dose time points was not possible due to insufficient data points.","reportingStatus":"POSTED","timeFrame":"Cycle 1: Post-dose on Days 1, 8 and 15; Cycle 2: Post-dose Day 1 (Each cycle is 56 days)","title":"CL: Total Clearance of TAK-186","type":"SECONDARY","unitOfMeasure":"liters per hours (L/h)"}