{"description":"The definition of adverse event and/or serious adverse event used to collect adverse event information does not differ from that of the clinicaltrials.gov.","eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":3,"description":"The study will employ the standard \"cohort of three\" design. Patients receive ABI-009 in level I dose - 56 mg/m\\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Dose Escalation Phase 1 Part I"},{"deathsNumAffected":3,"deathsNumAtRisk":3,"description":"The study will employ the standard \"cohort of three\" design. Patients receive ABI-009 in level II dose - 75 mg/m\\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Dose Escalation Phase 1 Part II"},{"deathsNumAffected":3,"deathsNumAtRisk":3,"description":"The study will employ the standard \"cohort of three\" design. Patients receive ABI-009 in level III dose - 100 mg/m\\^2 and defined dose of nivolumab - 240 mg IV 30 min. q 3 weeks.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Dose Escalation Phase 1 Part III"},{"deathsNumAffected":21,"deathsNumAtRisk":25,"description":"Following dose escalation, an additional 25 patients will receive ABI-009 at the MTD and defined doses of nivolumab to assess overall safety and potential efficacy in a greater number of patients. Patients in the expansion phase of the study may continue treatment up to 18 three-week cycles or until significant disease progression or unacceptable toxicity occurs.","id":"EG003","otherNumAffected":2,"otherNumAtRisk":25,"seriousNumAffected":3,"seriousNumAtRisk":25,"title":"Expansion Phase 1b"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Two patients developed Grade 2 oral mucositis.","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Oral mucositis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"One (3.2%) had acute dehydration.","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Three (9.7%) patients had thrombocytopenia.","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":25,"numEvents":3}],"term":"Thrombocytopenia"}],"timeFrame":"3.8 years"}