{"description":"1 subject withdrew consent before to starting treatment and no AEs were collected, so only 5 subjects were evaluated for AEs.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":5,"description":"All eligible patients will receive immunotherapy (Nivolumab) plus radiotherapy (6 Gy x 5 fractions) to a targetable lesion.\n\n* Nivolumab 240 mg IV starts with the first radiotherapy fraction 240 mg IV every 2 weeks from first radiotherapy fraction until disease prograssion or dose limiting toxicity is reached\n* Radiotherapy Dose of 6 Gy x 5 days will be given (patients will receive 1 fraction over 5 days for a total of 5 fractions) during the first week of starting Nivolumab\n\nNivolumab 240mg: Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached.\n\nRadiation therapy: Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Nivolumab/Radiotherapy"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3 Nausea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Peripheral motor neuropathy","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5,"numEvents":2}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Arthralgia","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Back pain","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Fatigue","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Myalgia","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Bloating","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 and Grade 2 Bone Pain","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":2}],"term":"bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3 Vomiting","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Diarrhea","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Creatinine increased","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3 Alkaline phosphatase increased","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Colitis - grade unknown","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 1 Pelvic pain","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"hip pain","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2 Alanine aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"elevated ALT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 2 Aspartate aminotransferase increased","organSystem":"Investigations","sourceVocabulary":"elevated AST","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 4 Hyperuricemia","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"elevated uric acid","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Hyperuricemia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 4 platelet count decreased","organSystem":"Investigations","sourceVocabulary":"Low platelet count","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3 Anemia","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Grade 3 back pain","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5,"numEvents":1}],"term":"Back pain"}],"timeFrame":"Adverse event data is collected from the date of consent until patients withdraw consent. Patients removed from the the study treatment due to disease progression or unacceptable toxicity will be followed until their adverse event returns to baseline values or until study completion, whichever occurs first, unless they withdraw consent."}