{"description":"Subjects and their parents reported any adverse symptoms or events via daily study medication logs. Site personnel reviewed logs at in-person visits at weeks 4, 8, 12, 16, 20 and 24 and assessed subject for any adverse events. All Adverse events and Serious Adverse events reviewed by independent DSMB.","eventGroups":[{"description":"Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Arm I- Cyproheptadine Hydrochloride"},{"description":"Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (\\> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.","id":"EG001","otherNumAffected":2,"otherNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"title":"Arm II Cyproheptadine HCl and PediaSure or Ensure"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":5,"numEvents":0}],"term":"somnolence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"relapse of cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"flatulence"}],"timeFrame":"24 weeks"}