{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"6.1","value":"12.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"}],"units":"Participants"}],"description":"PFS was defined as the period of time from treatment start to the first documentation of PD, recurrence, or death. PD was defined as a greater than or equal to 50% increase from baseline in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or non-responders, or the appearance of any new lesions during or at the end of therapy. PFS was censored at the last date for which the response assessment resulted in the absence of PD for participants who did not demonstrate objective progression or recurrence. Participants who withdrew prior to evidence of disease progression or recurrence, PFS was censored at the last date assessment showed an absence of PD.","dispersionType":"Standard Deviation","groups":[{"description":"Unblinded denileukin diftitox at 18 micrograms/kilogram/day (ug/kg/d) was administered intravenously (IV) on Days 1 and 2 of each 21-day cycle. Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) was administered on Day 3 of each 21-day cycle. On Day 4 of each 21-day cycle, pegfilgrastim (a granulocyte colony-stimulating factor (G-CSF)) was started as a prophylaxis to prevent neutropenia. After completion of two 21-day cycles, participants were evaluated for clinical response. Two 21-day cycles with denileukin and CHOP were repeated followed by response evaluations after each set of two 21-day cycles with intent to treat for 6 cycles, with a maximum of 8 cycles.","id":"OG000","title":"Denileukin Diftitox in Combination With CHOP"}],"paramType":"MEAN","populationDescription":"ITT population","reportingStatus":"POSTED","timeFrame":"From the date of first dose of study drug until date of first documentation of PD, recurrence, or death from any cause, assessed up to 5 years 9 months","title":"Progression-Free Survival","type":"SECONDARY","unitOfMeasure":"Weeks"}