{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"8"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"6"}]}],"title":"Grade 3+ Adverse Event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"1"},{"groupId":"OG005","value":"1"}]}],"title":"Grade 4+ Adverse Event"},{"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"}]}],"title":"Grade 5 Adverse Event"}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"5"},{"groupId":"OG005","value":"6"}],"units":"Participants"}],"description":"Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.","groups":[{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8","id":"OG000","title":"Treatment: Trial 1, Dose Level 1"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8","id":"OG001","title":"Treatment: Trial 1, Dose Level 2"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.\n\nPatients also receive:\n\n480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.\n\n50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.","id":"OG002","title":"Treatment: Trial 2, Dose Level 3"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.\n\nPatients also receive:\n\n480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.\n\n50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.","id":"OG003","title":"Treatment: Trial 2, Dose Level 4"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.\n\nPatients also receive:\n\n480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.\n\n50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.","id":"OG004","title":"Treatment: Trial 3, Dose Level 5"},{"description":"Patients receive:\n\nCycle 1:\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8\n\nCycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):\n\n250 mg/m\\^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.\n\nPatients also receive:\n\n480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.\n\n50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.","id":"OG005","title":"Treatment: Trial 3, Dose Level 6"}],"paramType":"NUMBER","populationDescription":"All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.","reportingStatus":"POSTED","timeFrame":"Assessed up to week 24","title":"Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)","type":"PRIMARY","unitOfMeasure":"participants"}