{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"}],"units":"Participants"}],"description":"Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.","groups":[{"description":"CTCL patients will receive 1000 mg/m2 of PXD101 IV\n\nbelinostat: 1000 mg/m2 for 5 days every 21 days; IV","id":"OG000","title":"Arm A (CTCL, ITT Population)"}],"paramType":"NUMBER","populationDescription":"At termination OR was noted in 1/13 patients (Simon Stage 1). With 29 patients in the CTCL arm the demand for expansion to Simon Stage 2 lacked 5 patients and the study was stopped. Instead OR was done as secondary efficacy analysis (ITT and PP (per protocol)) with OR calculated without accounting for Simon design and with 95% confidence intervals","reportingStatus":"POSTED","timeFrame":"throughout the study, or for a maximum of 2 years","title":"Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)","type":"POST_HOC","unitOfMeasure":"participants"}