{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"7"}],"units":"Participants"}],"description":"To determine the MTD of Betalutin that can be administered to DBLCL patients with lilotomab. The MTD was the highest dose at which less than two out of six participants experienced a dose limiting toxicity (DLT) defined as:\n\n* Haematologic toxicity:\n\n  * Grade 4 neutropenia observed for greater than 7 days' duration\n  * Grade 4 thrombocytopenia observed for greater than 7 days' duration\n  * Grade 3 or 4 neutropenia associated with fever (≥38.5°C) of any duration\n  * Grade 3 or 4 thrombocytopenia with bleeding\n  * Thrombocytopenia with any requirement for more than one platelet transfusion before recovering to Grade 1 or less\n  * Grade 4 anaemia, unexplained by underlying disease\n* Non-haematologic toxicity:\n\n  * Grade 3 nausea/vomiting/diarrhoea lasting longer than 72 hours despite maximal care or Grade 4\n  * Any other Grade 3 or 4 non-haematologic toxicities\n  * Any Grade 3 or 4 electrolyte abnormalities that do not resolve to Grade 1 or baseline within 24 hours","groups":[{"description":"Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 60 mg/m2 pre-dosing.","id":"OG000","title":"60/10"},{"description":"Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 10 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.","id":"OG001","title":"100/10"},{"description":"Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 15 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.","id":"OG002","title":"100/15"},{"description":"Betalutin® (lutetium (177Lu)-lilotomab satetraxetan) 20 MBq/kg, single injection with lilotomab 100 mg/m2 pre-dosing.","id":"OG003","title":"100/20"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"12 weeks","title":"Number of Participants With DLTs to Determine the MTD","type":"PRIMARY","unitOfMeasure":"Participants"}