{"eventGroups":[{"description":"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.\n\neverolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity","id":"EG000","otherNumAffected":6,"otherNumAtRisk":7,"seriousNumAffected":3,"seriousNumAtRisk":7,"title":"Patients Getting Everolimus"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7,"numEvents":4}],"term":"Albumin, low (hypoalbuminemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"ALT, SGPT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Bilirubin (hyperbilirubinemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7,"numEvents":4}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7,"numEvents":7}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7,"numEvents":6}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7,"numEvents":4}],"term":"Glucose, high (hyperglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Leukocytes (total WBC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Mood alteration - Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Neutrophils/granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Platelets"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Rigors/chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Sodium, low (hyponatremia)"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":2}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Inf norm ANC/gr1/2 neut-Myositis infection(muscle)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Inf norm ANC/gr1/2 neut-Cellulitis(skin)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Hemorrhage/Bleeding, other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTC-3.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1}],"term":"Ascites (non-malignant)"}]}