{"classes":[{"categories":[{"measurements":[{"comment":"The data is not evaluable as the samples were BLLQ.","groupId":"OG004","spread":"NA","value":"NA"},{"comment":"The data is not evaluable as the samples were BLLQ.","groupId":"OG005","spread":"NA","value":"NA"},{"comment":"The data is not evaluable as the samples were BLLQ.","groupId":"OG006","spread":"NA","value":"NA"},{"comment":"The data is not evaluable as the samples were BLLQ.","groupId":"OG007","spread":"NA","value":"NA"},{"comment":"The data is not evaluable as the samples were BLLQ.","groupId":"OG008","spread":"NA","value":"NA"},{"comment":"The data is not evaluable as the samples were BLLQ.","groupId":"OG009","spread":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"37"},{"groupId":"OG005","value":"39"},{"groupId":"OG006","value":"34"},{"groupId":"OG007","value":"33"},{"groupId":"OG008","value":"18"},{"groupId":"OG009","value":"19"}],"units":"Participants"}],"title":"Cycle 1 Day 2: Pre-dose"},{"categories":[{"measurements":[{"groupId":"OG004","spread":"665.6","value":"2130"},{"groupId":"OG005","spread":"222.7","value":"2810"},{"groupId":"OG006","spread":"550.9","value":"2740"},{"groupId":"OG007","spread":"1865.5","value":"1700"},{"groupId":"OG008","spread":"68.3","value":"3090"},{"groupId":"OG009","spread":"119.4","value":"3790"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"35"},{"groupId":"OG005","value":"38"},{"groupId":"OG006","value":"35"},{"groupId":"OG007","value":"31"},{"groupId":"OG008","value":"18"},{"groupId":"OG009","value":"19"}],"units":"Participants"}],"title":"Cycle 1 Day 2: 5 min Post Dose"},{"categories":[{"measurements":[{"groupId":"OG004","spread":"167.8","value":"456"},{"groupId":"OG005","spread":"187.9","value":"353"},{"groupId":"OG006","spread":"154.2","value":"518"},{"groupId":"OG007","spread":"380.2","value":"451"},{"groupId":"OG008","spread":"111.4","value":"478"},{"groupId":"OG009","spread":"165.6","value":"639"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"35"},{"groupId":"OG005","value":"39"},{"groupId":"OG006","value":"34"},{"groupId":"OG007","value":"31"},{"groupId":"OG008","value":"17"},{"groupId":"OG009","value":"18"}],"units":"Participants"}],"title":"Cycle 1 Day 2: 1h Post Dose"},{"categories":[{"measurements":[{"groupId":"OG004","spread":"173.5","value":"84.4"},{"groupId":"OG005","spread":"236.5","value":"55.1"},{"groupId":"OG006","spread":"250.5","value":"93.8"},{"groupId":"OG007","spread":"375.8","value":"101"},{"groupId":"OG008","spread":"104.3","value":"62.8"},{"groupId":"OG009","spread":"196.7","value":"128"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"34"},{"groupId":"OG005","value":"39"},{"groupId":"OG006","value":"34"},{"groupId":"OG007","value":"33"},{"groupId":"OG008","value":"17"},{"groupId":"OG009","value":"16"}],"units":"Participants"}],"title":"Cycle 1 Day 2: 2h Post Dose"},{"categories":[{"measurements":[{"groupId":"OG004","spread":"220.1","value":"20.5"},{"groupId":"OG005","spread":"246.4","value":"12.7"},{"groupId":"OG006","spread":"461.0","value":"23.5"},{"groupId":"OG007","spread":"509.9","value":"21.5"},{"groupId":"OG008","spread":"132.0","value":"12.4"},{"groupId":"OG009","spread":"287.4","value":"28.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"33"},{"groupId":"OG005","value":"38"},{"groupId":"OG006","value":"34"},{"groupId":"OG007","value":"32"},{"groupId":"OG008","value":"17"},{"groupId":"OG009","value":"15"}],"units":"Participants"}],"title":"Cycle 1 Day 2: 3h Post Dose"},{"categories":[{"measurements":[{"groupId":"OG004","spread":"278.5","value":"7.60"},{"groupId":"OG005","spread":"268.4","value":"4.58"},{"groupId":"OG006","spread":"724.8","value":"8.11"},{"groupId":"OG007","spread":"615.9","value":"8.08"},{"groupId":"OG008","spread":"147.2","value":"3.30"},{"groupId":"OG009","spread":"131.0","value":"6.18"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"31"},{"groupId":"OG005","value":"37"},{"groupId":"OG006","value":"31"},{"groupId":"OG007","value":"33"},{"groupId":"OG008","value":"17"},{"groupId":"OG009","value":"15"}],"units":"Participants"}],"title":"Cycle 1 Day 2: 4h Post Dose"}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"37"},{"groupId":"OG005","value":"39"},{"groupId":"OG006","value":"35"},{"groupId":"OG007","value":"33"},{"groupId":"OG008","value":"18"},{"groupId":"OG009","value":"19"}],"units":"Participants"}],"description":"Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol plasma concentration of bendamustine was not assessed in the Phase II NF Cohort (Arm G+H).","dispersionType":"Geometric Coefficient of Variation","groups":[{"description":"Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.","id":"OG000","title":"Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL"},{"description":"Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.","id":"OG001","title":"Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL"},{"description":"Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.","id":"OG002","title":"Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL"},{"description":"Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.","id":"OG003","title":"Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL"},{"description":"Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.","id":"OG004","title":"Arm A (Phase II Randomization): Pola+BR in FL"},{"description":"Participants with FL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.","id":"OG005","title":"Arm B (Phase II Randomization): BR in FL"},{"description":"Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.","id":"OG006","title":"Arm C (Phase II Randomization): Pola+BR in DLBCL"},{"description":"Participants with DLBCL received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\\^2, as IV infusion on Day 1 of Cycles 1 to 6.","id":"OG007","title":"Arm D (Phase II Randomization): BR in DLBCL"},{"description":"Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.","id":"OG008","title":"Arm E (Phase II Expansion): Pola+BG in FL"},{"description":"Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.","id":"OG009","title":"Arm F (Phase II Expansion): Pola+BG in DLBCL"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"PK evaluable population included all the ITT participants Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.","reportingStatus":"POSTED","timeFrame":"Cycle 1 Day 2: pre-dose, 5 min, 1 hour (h); 2h, 3h and 4h post dose","title":"Plasma Concentration of Bendamustine","type":"SECONDARY","unitOfMeasure":"ng/mL"}