{"description":"The sample size for this section is the number of participants who had post-randomization toxicity data recorded.","eventGroups":[{"description":"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.\n\nmemantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.","id":"EG000","otherNumAffected":48,"otherNumAtRisk":57,"seriousNumAffected":5,"seriousNumAtRisk":57,"title":"Arm I - Memantine"},{"description":"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.\n\nplacebo: Placebo by mouth through completion of 12 weeks.","id":"EG001","otherNumAffected":51,"otherNumAtRisk":59,"seriousNumAffected":3,"seriousNumAtRisk":59,"title":"Arm II - Placebo"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":57,"numEvents":54},{"groupId":"EG001","numAffected":12,"numAtRisk":59,"numEvents":38}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":57,"numEvents":21},{"groupId":"EG001","numAffected":5,"numAtRisk":59,"numEvents":9}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":57,"numEvents":31},{"groupId":"EG001","numAffected":13,"numAtRisk":59,"numEvents":27}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":57,"numEvents":69},{"groupId":"EG001","numAffected":27,"numAtRisk":59,"numEvents":72}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":57,"numEvents":12},{"groupId":"EG001","numAffected":10,"numAtRisk":59,"numEvents":15}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":57,"numEvents":25},{"groupId":"EG001","numAffected":10,"numAtRisk":59,"numEvents":22}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":57,"numEvents":55},{"groupId":"EG001","numAffected":16,"numAtRisk":59,"numEvents":40}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":57,"numEvents":83},{"groupId":"EG001","numAffected":25,"numAtRisk":59,"numEvents":66}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":57,"numEvents":33},{"groupId":"EG001","numAffected":19,"numAtRisk":59,"numEvents":33}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":57,"numEvents":31},{"groupId":"EG001","numAffected":13,"numAtRisk":59,"numEvents":37}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":5,"numAtRisk":59,"numEvents":15}],"term":"Renal and Urinary Disorder - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":57,"numEvents":23},{"groupId":"EG001","numAffected":8,"numAtRisk":59,"numEvents":17}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":57,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":2}],"term":"Vomiting"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":59,"numEvents":7}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":57,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":59,"numEvents":1}],"term":"Liver Dysfunction / Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":57,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":59,"numEvents":0}],"term":"Retinal Tear"}],"timeFrame":"4 months (3 months of treatment and 1 month following the end of treatment)"}