{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"15"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"15"},{"groupId":"OG004","value":"4"},{"groupId":"OG005","value":"0"}],"units":"Participants"}],"description":"Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.","groups":[{"description":"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\\^2 on day 1 of 21 day cycle\n\nOther Names:\n\n• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle\n\nOther Names:\n\n• Cytoxan Drug: SS1 (dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg days 10, 12, and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.","id":"OG000","title":"Mesothelioma Pilot Phase Regimen A"},{"description":"Drug: Pentostatin Regimen B: Cycle 1: 4 mg/m\\^2 or 2 mg/m\\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\\^2 on days 1 and 5 of 25 day cycle Regimen B: Cycle 1: 4 mg/m\\^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m\\^2 on days 1 and 5 of 25 day cycle\n\nOther Names:\n\n• Nipent Drug: Cyclophosphamide Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle\n\nOther Names:\n\n• Cytoxan Drug: SS1 (dsFv)PE38 Regimen B: Cycle 1: 35mcg/kg days 18, 20, and 22. Cycles 2-4: (Days 6, 8, and 10), for a maximum of six treatment cycles.","id":"OG001","title":"Mesothelioma Pilot Phase Regimen B"},{"description":"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\\^2 on day 1 of 21 day cycle\n\nOther Names:\n\n• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle\n\nOther Names:\n\n• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.","id":"OG002","title":"Phase 2 Peritoneal Mesothelioma Pilot Expansion Phase"},{"description":"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\\^2 on day 1 of 21 day cycle\n\nOther Names:\n\n• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle\n\nOther Names:\n\n• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.","id":"OG003","title":"Phase 2 Pleural Mesothelioma Pilot Expansion Phase"},{"description":"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\\^2 on day 1 of 21 day cycle\n\nOther Names:\n\n• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle\n\nOther Names:\n\n• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.","id":"OG004","title":"Phase 2 Pancreatic Adenocarcinoma Pilot Phase Regimen A"},{"description":"Drug: Pentostatin Regimen A: Cycle 1: 4 mg/m\\^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m\\^2 on day 1 of 21 day cycle\n\nOther Names:\n\n• Nipent Drug: Cyclophosphamide Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle\n\nOther Names:\n\n• Cytoxan Drug: SS1(dsFv)PE38 Regimen A: Cycle 1: 35 mcg/kg or 25 mcg/kg days 10, 12 and 14. Cycles 2-4: Days 2, 4, and 6, for a maximum of six treatment cycles.","id":"OG005","title":"Phase 2 Lung Adenocarcinoma Pilot Expansion Phase Regimen A"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"No pts. were enrolled in the Phase 2 Lung Adenocarcinoma Pilot group.","reportingStatus":"POSTED","timeFrame":"Date treatment consent signed to date off study, approximately 64 months and 26 days","title":"Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) Who Were Administered SS1P and Pentostatin or Cyclophosphamide","type":"PRIMARY","unitOfMeasure":"Participants"}