{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"},{"groupId":"OG004","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"4"},{"groupId":"OG004","value":"5"}],"units":"Participants"}],"description":"Number (percentage) of patients experiencing a DLT during the first cycle (28 days) of study treatment in Phase 1b, defined as an adverse event (AE) or clinically significant abnormal laboratory value that was at least possibly related to study drugs and was not primarily related to disease, disease progression, concomitant medication(s), or intercurrent illness. In addition, to be considered a DLT, the AE had to meet at least one of the following criteria:\n\n* Grade 4 anemia unexplained by underlying disease\n* Grade 4 febrile neutropenia\n* Grade 4 neutropenia lasting \\>5 days\n* Any other Grade 4 hematologic toxicity (thrombocytopenia, neutropenia, febrile neutropenia, anemia) of any duration\n* Grade 4 or higher tumor lysis syndrome\n* Grade 3 or higher thrombocytopenia (with or without bleeding)\n* Any requirement for platelet transfusion\n* Grade 3 or higher non-hematologic toxicity despite adequate supportive care\n* Results in a dose hold of \\>7 consecutive days","groups":[{"description":"VRx-3996: 10 mg twice daily (BID) valganciclovir: 900 mg BID","id":"OG000","title":"Phase 1b Dose Escalation Cohort 1"},{"description":"VRx-3996: 5 mg BID valganciclovir: 450 mg BID","id":"OG001","title":"Phase 1b Dose Escalation Cohort 2a"},{"description":"VRx-3996: 10 mg once daily (QD) valganciclovir: 450 mg BID","id":"OG002","title":"Phase 1b Dose Escalation Cohort 2b"},{"description":"VRx-3996: 10 mg QD valganciclovir: 900 mg QD","id":"OG003","title":"Phase 1b Dose Escalation Cohort 2c"},{"description":"VRx-3996: 20 mg QD on Days 1 to 4/week valganciclovir: 900 mg QD","id":"OG004","title":"Phase 1b Dose Escalation Cohort 3 (RP2D)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Analysis Set, defined as all enrolled patients who received at least 1 dose of study treatment. Valganciclovir dosage reductions were allowed for participants with renal impairment at study entry or during study treatment.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (28 days)","title":"Number (Proportion) of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b","type":"PRIMARY","unitOfMeasure":"Participants"}