{"classes":[{"categories":[{"measurements":[{"comment":"This study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined","groupId":"OG000","value":"NA"},{"comment":"This study was stopped prior to the MTD being defined. Accordingly, there was no RP2D determined","groupId":"OG001","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}],"units":"Participants"}],"description":"Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) determined by incidence of dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the severity grade","groups":[{"description":"Participants received 33 kiloBecquerel (kBq)/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX","id":"OG000","title":"Radium-223 Dichloride 33 kBq/kg + Bortezomib and Dexamethasone"},{"description":"Participants received 55 kBq/kg body weight every 6 weeks for a total of 6 radium-223 dichloride doses in combination with BOR and DEX","id":"OG001","title":"Radium-223 Dichloride 55 kBq/kg + Bortezomib and Dexamethasone"}],"paramType":"NUMBER","populationDescription":"The safety analysis set including all participants who received at least one administration of study treatment","reportingStatus":"POSTED","timeFrame":"From the start of study medication through 3 weeks after administration of the second dose of radium-223 dichloride, assessed up to 9 weeks","title":"Phase 1: MTD/RP2D Determined by the Incidence of DLTs","type":"PRIMARY","unitOfMeasure":"KBq/kg"}