{"description":"All-Cause Mortality was monitored in for all enrolled 75 participants ( 1 participant died before receiving treatment and 4 while on study) and 74 participants with Serious and Other Adverse Events.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":75,"description":"Participants with refractory or relapsed myeloma received high-dose GemBuMel with ASCT.","id":"EG000","otherNumAffected":71,"otherNumAtRisk":74,"seriousNumAffected":31,"seriousNumAtRisk":74,"title":"Gemcitabine/Busulfan/Melphalan"}],"frequencyThreshold":"1","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":74}],"term":"Mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":74}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":74}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":74}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":74}],"term":"Cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":74}],"term":"Hyperbilirubinemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":74}],"term":"Hand-foot syndrome"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":74}],"term":"Mucositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":74}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":74}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":74}],"term":"Cardiac"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTC AE v3.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":74}],"term":"Hyperbilirubinemia"}],"timeFrame":"Up to 2 years"}