{"classes":[{"categories":[{"measurements":[{"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":"2"},{"groupId":"OG008","value":"0"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"3"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"7"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"2"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"4"},{"groupId":"OG010","value":"5"},{"groupId":"OG011","value":"5"},{"groupId":"OG012","value":"6"},{"groupId":"OG013","value":"5"}],"units":"Participants"}],"description":"DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0.","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"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The DLT-evaluable analysis set included participants who received all required doses of TAK-500 (with pembrolizumab if in a combination cohort) and remain on study for 21 days from first dosing of TAK-500 (through C1D21) without experiencing a DLT or who have a DLT during the first 21 days after study drug administration.","reportingStatus":"POSTED","timeFrame":"Up to Cycle 1 (1 cycle = 21 days)","title":"Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}