{"description":"All adverse events related to MILs or vaccine administration were collected. Adverse events related to ASCT were not collected.","eventGroups":[{"deathsNumAffected":7,"deathsNumAtRisk":17,"description":"Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":17,"seriousNumAffected":0,"seriousNumAtRisk":17,"title":"ASCT + MILs"},{"deathsNumAffected":6,"deathsNumAtRisk":18,"description":"Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.","id":"EG001","otherNumAffected":15,"otherNumAtRisk":18,"seriousNumAffected":0,"seriousNumAtRisk":18,"title":"ASCT + MILs + Vaccine"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":17,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":18,"numEvents":6}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Flu-like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":14,"numAtRisk":18,"numEvents":40}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Pruritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":17,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":18,"numEvents":3}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":17,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":18,"numEvents":1}],"term":"Thrombocytopenia"}],"timeFrame":"Up to 1 year"}