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Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.","id":"EG000","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":5,"seriousNumAtRisk":18,"title":"Phase I"},{"description":"Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.","id":"EG001","otherNumAffected":99,"otherNumAtRisk":101,"seriousNumAffected":32,"seriousNumAtRisk":101,"title":"Phase II"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18,"numEvents":2},{"groupId":"EG001","numAffected":9,"numAtRisk":101,"numEvents":17}],"term":"Hemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 9","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":18,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":101,"numEvents":1}],"term":"Hemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 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