{"description":"Complete and frequent monitoring for adverse events (AEs) were incorporated using the Systematic Assessment for Treatment Emergent Effects (SAFTEE),developed by the National Institute of Mental Health. AEs will also be assessed by weekly physical exam, review of patient/caregiver daily sleep and medicine logs and patient/caregiver interview.","eventGroups":[{"description":"Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Arm I - Methylphenidate Hydrochloride"},{"description":"Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Arm II -Modafinil"},{"description":"Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Arm III Placebo"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"decreased appetite"}],"timeFrame":"1 month"}