{"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"},{"groupId":"OG005","value":"0"},{"groupId":"OG006","value":"0"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"0"}],"units":"Participants"}],"groups":[{"description":"Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year.","id":"OG000","title":"Single Agent Dose Escalation: TAK-500 8 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.","id":"OG001","title":"Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg"},{"description":"Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.","id":"OG002","title":"Single Agent Dose Escalation: TAK-500 16 µg/kg"},{"description":"Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.","id":"OG003","title":"Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.","id":"OG004","title":"Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"OG005","title":"Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"OG006","title":"Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"OG007","title":"Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"OG008","title":"Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"OG009","title":"Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.","id":"OG010","title":"Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg"},{"description":"Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year.","id":"OG011","title":"Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"OG012","title":"Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg"},{"description":"Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year.","id":"OG013","title":"Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg"}],"populationDescription":"Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported.","reportingStatus":"POSTED","timeFrame":"Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days)","title":"Dose Escalation: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500","type":"SECONDARY"}