{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"DLTs are defined as: Any treatment-related Grade \\>=3 non-hematologic clinical (non-laboratory) adverse event (AE); Any treatment-related Grade 3 or Grade 4 non-hematologic laboratory (lab) abnormality if Medical intervention is required to treat the participant or the abnormality leads to hospitalization or the abnormality persists for \\>=7 days; Any treatment-related hematologic toxicity specifically defined as: Thrombocytopenia Grade 4 for \\>=7 days, or Grade 3 or 4 associated with bleeding or requiring platelet transfusion, Neutropenia Grade 4 for \\>=7 days, or Grade 3 or 4 associated with infection or febrile neutropenia, Anemia Grade 4, or Grade 3 or 4 requiring blood transfusion; Any treatment-related AE leading to niraparib dose interruption per the following criteria: A dose interruption for a non-DLT lab abnormality lasting \\>=14 days, A dose in interruption per dose modification rules for non-hematologic AE leading to \\<80 percent (%) of an intended dose being administered.","groups":[{"description":"Participants received Niraparib 200 milligrams (mg) orally once daily from Days 1 to 21 and Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle.","id":"OG000","title":"Phase 1: Niraparib 200 mg + Pembrolizumab"},{"description":"Participants received Niraparib 300 mg orally once daily from Days 1 to 21 and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.","id":"OG001","title":"Phase 1: Niraparib 300 mg + Pembrolizumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"DLT Analysis Set comprised of all Phase 1 participants who completed the first cycle of therapy. The assessment of DLTs in Phase 1 included only those participants completing the first cycle of therapy, unless the participant discontinued study drug due to a DLT. Only those participants with data available at specified data point were analyzed.","reportingStatus":"POSTED","timeFrame":"During Cycle 1, ie, during the first 21 days of treatment","title":"Phase 1: Number of Participants Reporting Dose-Limiting Toxicities (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}