{"description":"All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.","eventGroups":[{"deathsNumAffected":31,"deathsNumAtRisk":135,"description":"IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.\n\nIMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C.\n\nPatients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nComputed Tomography: Undergo CT\n\nEchocardiography Test: Undergo ECHO\n\nIpilimumab: Given IV\n\nMultigated Acquisition Scan: Undergo MUGA scan\n\nNivolumab: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"EG000","otherNumAffected":124,"otherNumAtRisk":131,"seriousNumAffected":83,"seriousNumAtRisk":131,"title":"Arm A (Immunotherapy)"},{"deathsNumAffected":49,"deathsNumAtRisk":132,"description":"Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D.\n\nPatients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nComputed Tomography: Undergo CT\n\nDabrafenib Mesylate: Given PO\n\nEchocardiography Test: Undergo ECHO\n\nMultigated Acquisition Scan: Undergo MUGA scan\n\nQuality-of-Life Assessment: Ancillary studies\n\nTrametinib Dimethyl Sulfoxide: Given PO","id":"EG001","otherNumAffected":129,"otherNumAtRisk":132,"seriousNumAffected":75,"seriousNumAtRisk":132,"title":"Arm B (BRAF Inhibitor Therapy)"},{"deathsNumAffected":16,"deathsNumAtRisk":30,"description":"Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.\n\nPatients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nComputed Tomography: Undergo CT\n\nDabrafenib Mesylate: Given PO\n\nEchocardiography Test: Undergo ECHO\n\nMultigated Acquisition Scan: Undergo MUGA scan\n\nQuality-of-Life Assessment: Ancillary studies\n\nTrametinib Dimethyl Sulfoxide: Given PO","id":"EG002","otherNumAffected":29,"otherNumAtRisk":29,"seriousNumAffected":17,"seriousNumAtRisk":29,"title":"Arm C (BRAF Inhibitor Therapy)"},{"deathsNumAffected":29,"deathsNumAtRisk":52,"description":"IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity.\n\nIMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity.\n\nPatients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial.\n\nBiospecimen Collection: Undergo collection of blood samples\n\nComputed Tomography: Undergo CT\n\nEchocardiography Test: Undergo ECHO\n\nIpilimumab: Given IV\n\nMultigated Acquisition Scan: Undergo MUGA scan\n\nNivolumab: Given IV\n\nQuality-of-Life Assessment: Ancillary studies","id":"EG003","otherNumAffected":44,"otherNumAtRisk":52,"seriousNumAffected":24,"seriousNumAtRisk":52,"title":"Arm D (Immunotherapy)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":131},{"groupId":"EG001","numAffected":46,"numAtRisk":132},{"groupId":"EG002","numAffected":8,"numAtRisk":29},{"groupId":"EG003","numAffected":10,"numAtRisk":52}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":131},{"groupId":"EG001","numAffected":7,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":4,"numAtRisk":52}],"term":"Blood and lymphatic system disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":131},{"groupId":"EG001","numAffected":2,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":0,"numAtRisk":52}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":131},{"groupId":"EG001","numAffected":47,"numAtRisk":132},{"groupId":"EG002","numAffected":9,"numAtRisk":29},{"groupId":"EG003","numAffected":2,"numAtRisk":52}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":131},{"groupId":"EG001","numAffected":23,"numAtRisk":132},{"groupId":"EG002","numAffected":4,"numAtRisk":29},{"groupId":"EG003","numAffected":3,"numAtRisk":52}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":81,"numAtRisk":131},{"groupId":"EG001","numAffected":92,"numAtRisk":132},{"groupId":"EG002","numAffected":18,"numAtRisk":29},{"groupId":"EG003","numAffected":32,"numAtRisk":52}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":131},{"groupId":"EG001","numAffected":72,"numAtRisk":132},{"groupId":"EG002","numAffected":16,"numAtRisk":29},{"groupId":"EG003","numAffected":11,"numAtRisk":52}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":131},{"groupId":"EG001","numAffected":11,"numAtRisk":132},{"groupId":"EG002","numAffected":2,"numAtRisk":29},{"groupId":"EG003","numAffected":2,"numAtRisk":52}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":131},{"groupId":"EG001","numAffected":0,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":3,"numAtRisk":52}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":131},{"groupId":"EG001","numAffected":0,"numAtRisk":132},{"groupId":"EG002","numAffected":2,"numAtRisk":29},{"groupId":"EG003","numAffected":2,"numAtRisk":52}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":131},{"groupId":"EG001","numAffected":7,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":0,"numAtRisk":52}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":131},{"groupId":"EG001","numAffected":8,"numAtRisk":132},{"groupId":"EG002","numAffected":1,"numAtRisk":29},{"groupId":"EG003","numAffected":3,"numAtRisk":52}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":131},{"groupId":"EG001","numAffected":11,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":3,"numAtRisk":52}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":131},{"groupId":"EG001","numAffected":9,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":0,"numAtRisk":52}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":131},{"groupId":"EG001","numAffected":30,"numAtRisk":132},{"groupId":"EG002","numAffected":8,"numAtRisk":29},{"groupId":"EG003","numAffected":20,"numAtRisk":52}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":131},{"groupId":"EG001","numAffected":0,"numAtRisk":132},{"groupId":"EG002","numAffected":3,"numAtRisk":29},{"groupId":"EG003","numAffected":1,"numAtRisk":52}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":70,"numAtRisk":131},{"groupId":"EG001","numAffected":44,"numAtRisk":132},{"groupId":"EG002","numAffected":7,"numAtRisk":29},{"groupId":"EG003","numAffected":20,"numAtRisk":52}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":131},{"groupId":"EG001","numAffected":0,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":0,"numAtRisk":52}],"term":"Skin hypopigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":131},{"groupId":"EG001","numAffected":11,"numAtRisk":132},{"groupId":"EG002","numAffected":7,"numAtRisk":29},{"groupId":"EG003","numAffected":7,"numAtRisk":52}],"term":"Skin and subcutaneous tissue disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":131},{"groupId":"EG001","numAffected":0,"numAtRisk":132},{"groupId":"EG002","numAffected":1,"numAtRisk":29},{"groupId":"EG003","numAffected":7,"numAtRisk":52}],"term":"Adrenal insufficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":131},{"groupId":"EG001","numAffected":0,"numAtRisk":132},{"groupId":"EG002","numAffected":1,"numAtRisk":29},{"groupId":"EG003","numAffected":6,"numAtRisk":52}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":41,"numAtRisk":131},{"groupId":"EG001","numAffected":4,"numAtRisk":132},{"groupId":"EG002","numAffected":3,"numAtRisk":29},{"groupId":"EG003","numAffected":19,"numAtRisk":52}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":131},{"groupId":"EG001","numAffected":0,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":4,"numAtRisk":52}],"term":"Endocrine disorders - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":131},{"groupId":"EG001","numAffected":14,"numAtRisk":132},{"groupId":"EG002","numAffected":5,"numAtRisk":29},{"groupId":"EG003","numAffected":3,"numAtRisk":52}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":131},{"groupId":"EG001","numAffected":16,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":0,"numAtRisk":52}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":131},{"groupId":"EG001","numAffected":51,"numAtRisk":132},{"groupId":"EG002","numAffected":10,"numAtRisk":29},{"groupId":"EG003","numAffected":16,"numAtRisk":52}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":131},{"groupId":"EG001","numAffected":7,"numAtRisk":132},{"groupId":"EG002","numAffected":1,"numAtRisk":29},{"groupId":"EG003","numAffected":4,"numAtRisk":52}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":131},{"groupId":"EG001","numAffected":0,"numAtRisk":132},{"groupId":"EG002","numAffected":1,"numAtRisk":29},{"groupId":"EG003","numAffected":3,"numAtRisk":52}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":131},{"groupId":"EG001","numAffected":8,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":0,"numAtRisk":52}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":131},{"groupId":"EG001","numAffected":57,"numAtRisk":132},{"groupId":"EG002","numAffected":11,"numAtRisk":29},{"groupId":"EG003","numAffected":10,"numAtRisk":52}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":131},{"groupId":"EG001","numAffected":37,"numAtRisk":132},{"groupId":"EG002","numAffected":3,"numAtRisk":29},{"groupId":"EG003","numAffected":7,"numAtRisk":52}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":131},{"groupId":"EG001","numAffected":43,"numAtRisk":132},{"groupId":"EG002","numAffected":5,"numAtRisk":29},{"groupId":"EG003","numAffected":15,"numAtRisk":52}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":131},{"groupId":"EG001","numAffected":40,"numAtRisk":132},{"groupId":"EG002","numAffected":5,"numAtRisk":29},{"groupId":"EG003","numAffected":7,"numAtRisk":52}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":131},{"groupId":"EG001","numAffected":46,"numAtRisk":132},{"groupId":"EG002","numAffected":6,"numAtRisk":29},{"groupId":"EG003","numAffected":10,"numAtRisk":52}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":131},{"groupId":"EG001","numAffected":8,"numAtRisk":132},{"groupId":"EG002","numAffected":0,"numAtRisk":29},{"groupId":"EG003","numAffected":0,"numAtRisk":52}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":131},{"groupId":"EG001","numAffected":26,"numAtRisk":132},{"groupId":"EG002","numAffected":2,"numAtRisk":29},{"groupId":"EG003","numAffected":2,"numAtRisk":52}],"term":"CPK increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 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