{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"24"}]}],"title":"Anemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"16"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Nausea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12.0"}]}],"title":"Platelet count decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"36.0"}]}],"title":"Neutrophil count decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"52.0"}]}],"title":"Lymphocyte count decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20.0"}]}],"title":"White blood cell decreased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Rash maculo-papular"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12.0"}]}],"title":"Hyperglycemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"}]}],"title":"Lymphocyte count increased"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12.0"}]}],"title":"Syncope"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Hyperuricemia"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Hypotension"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Lung infection"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Pain in extremity"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Sepsis"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4.0"}]}],"title":"Uriticaria"}],"denoms":[{"counts":[{"groupId":"OG000","value":"25"}],"units":"Participants"}],"description":"The maximum grade for each type of adverse event, regardless of causality, will be recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event are reported below.","groups":[{"description":"Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"Up to 30 days after the last day of study drug treatment","title":"Incidence of Toxicities Graded Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (All Treatment)","type":"SECONDARY","unitOfMeasure":"percentage of patients"}