{"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":"OG008","value":"0"},{"groupId":"OG009","value":"0"},{"groupId":"OG010","value":"0"},{"groupId":"OG011","value":"0"},{"groupId":"OG012","value":"0"},{"groupId":"OG013","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"3"},{"groupId":"OG005","value":"4"},{"groupId":"OG006","value":"3"},{"groupId":"OG007","value":"0"},{"groupId":"OG008","value":"6"},{"groupId":"OG009","value":"2"},{"groupId":"OG010","value":"4"},{"groupId":"OG011","value":"4"},{"groupId":"OG012","value":"5"},{"groupId":"OG013","value":"2"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants who achieve cPR or cCR (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per RECIST Version 1.1. CR: defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \\<10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response.","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":"NUMBER","populationDescription":"The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation.","reportingStatus":"POSTED","timeFrame":"Up to approximately 32.8 months","title":"Dose Escalation: Overall Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"percentage of participants"}