{"description":"The primary endpoint is the incidence of NCI-CTCAE 4.0 grade 3 or higher GI toxicity in the 14 days following autologous HSCT","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":49,"description":"* Two 8 oz. bottles of Enterade will be administered daily\n* Enterade will be given orally from admission until day +14 or until discharge\n* Standard Supportive Care will be administered according to institution's practice\n\nEnterade\n\nStandard Supportive Care","id":"EG000","otherNumAffected":18,"otherNumAtRisk":49,"seriousNumAffected":0,"seriousNumAtRisk":49,"title":"Enterade and Standard Supportive Care"},{"deathsNumAffected":1,"deathsNumAtRisk":50,"description":"* Two 8 oz. bottles of Placebo will be administered daily\n* Placebo will be given orally from admission until day +14 or until discharge\n* Standard Supportive Care will be administered according to institution's practice\n\nPlacebo\n\nStandard Supportive Care","id":"EG001","otherNumAffected":21,"otherNumAtRisk":50,"seriousNumAffected":1,"seriousNumAtRisk":50,"title":"Placebo and Standard Supportive Care"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":49},{"groupId":"EG001","numAffected":3,"numAtRisk":50}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":49},{"groupId":"EG001","numAffected":12,"numAtRisk":50}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":5,"numAtRisk":50}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":49},{"groupId":"EG001","numAffected":0,"numAtRisk":50}],"term":"Nausea"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAtRisk":49},{"groupId":"EG001","numAffected":1,"numAtRisk":50}],"term":"Clostridium septicum septic shock"}],"timeFrame":"14 days"}