{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Febrile neutropenia (grade 3) Prob Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Febrile neutropenia (grade 3) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Fever (grade 3) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Fever (grade 2) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Thrombosis/embolism (grade 3) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Neutrophils (grade 3) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"}]}],"title":"Neutrophils (grade 4) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Left vent. diastolic dysfunct. (grade 1) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Allergic reaction (grade 4) Def Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Platelets (grade 4) Prob Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Platelets (grade 4) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Dyspnea (grade 3) Prob Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Pneumonitis (grade 3) Prob Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Lung Inf, 0-2 ANC: lung (grade 3) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Leukocytes (grade 4) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Leukocytes (grade 4) Prob Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}],"title":"Lymphopenia (grade 4) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Inf, 3-4 ANC: cath-related (grade 3) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Allergy-other (grade 1) Def Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Infection-other (grade 3) Poss Rrel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Cardiac ischemia (grade 5) Def Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Tumor lysis syndrome (grade 5) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Cardiopulmonary arrest (grade 4) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Supra Arrhyth: Sinus Tachy. (grade 4) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Death, NOS (grade 5) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Edema-limb (grade 1) Poss Rel"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"}]}],"title":"Pain-other (grade 3) Poss Rel"}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"}],"units":"Participants"}],"description":"A serious adverse event (SAE) was any AE that occurred at any dose and resulted in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that did not result in death, were life-threatening, or required hospitalization were considered a SAE when based upon appropriate medical judgment, jeopardized the participant and required medical or surgical intervention to prevent one of the outcomes listed above. Possibly Related (Poss Rel) applied to AEs judged to be perhaps related to study medication, Probably Related (Prob Rel) applied to AEs judged to have a high degree of certainty as related to study medication, and Definitely Related (Def Rel) related applied to AEs that were judged to be without a doubt related to study medication.","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":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"From date of first dose up to approximately 4 weeks after discontinuation of denileukin diftitox and CHOP, or after early withdrawal for any reason, up to approximately 5 years 9 months","title":"Summary of Study Drug-Related (Possible, Probable, or Definite) Serious Adverse Events","type":"PRIMARY","unitOfMeasure":"Participants"}