{"description":"NCI Common Terminology Criteria for Adverse Events version 3 was used to grade toxicities. The drug manufacturer, Berlex, required the reporting of all Serious Adverse Events associated with the study to Berlex Global Medical Safety Surveillance Group.","eventGroups":[{"description":"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors\n\nPreparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.\n\nSubject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.","id":"EG000","otherNumAffected":48,"otherNumAtRisk":48,"seriousNumAffected":36,"seriousNumAtRisk":48,"title":"Campath Purged Non-myeloablative ASCT"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Allergic reaction / hypersensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":48,"numEvents":9}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":48,"numEvents":4}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"fever of unknown origin without clinically or microbiologically documented infection)(ANC \\<1.0 x 10e9/L, fever \\>=38.5 degrees C","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":48,"numEvents":21}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48,"numEvents":4}],"term":"Creatinine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":2}],"term":"Neuropathy: motor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Neuropathy: sensory"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Seizure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"shortness of breath","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"lack of oxygen","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":48,"numEvents":6}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":48,"numEvents":4}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Failure to engraft"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":2}],"term":"Ventricular arrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":48,"numEvents":3}],"term":"Cardiac Left Ventricular Function"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":48,"numEvents":16}],"term":"Infection with Grade 3 or 4 neutrophils"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":48,"numEvents":6}],"term":"Infection with normal ANC or Grade 1/2 neutrophils"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (2.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":48,"numEvents":36}],"term":"Death"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"e.g. thrombotic thrombocytopenic purpura \\[TTP\\] or hemolytic uremic syndrome \\[HUS\\]","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":48,"numEvents":1}],"term":"Thrombotic microangiopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 2.0 and 3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":48,"numEvents":6}],"term":"Hemorrhage"}],"timeFrame":"Toxicities were formally recorded for all patients twice weekly for the first 100 days, at each follow up visit, and as needed intercurrently, up to 10 years"}