{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"31"}]}],"title":"Any adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"31"}]}],"title":"Any non-haematologic adverse event"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"22"}]}],"title":"Severe adverse event (grade 3 or 4)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"31"}]}],"title":"Treatment-related adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"5"}]}],"title":"Deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"7"}]}],"title":"Serious adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"5"}]}],"title":"Withdrawn from study due to AE"}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"31"}],"units":"Participants"}],"description":"Counts of participants who had AEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0. Severity is rated on a 5-point scale: 1=mild, 2=moderate, 3=severe, 4=life threatening or disabling, and 5= death related to AE. Relatedness is assessed on a 5-point scale: not related, unlikely, possible, probable and definite. Definite, probable and possible answers are reported as 'related' to study medication. Deaths are reported up to 18 months. All the deaths occurred beyond the treatment-emergent timeframe since they occurred 6.5-16 months after the final dosing. All other parts of the summary represent the treatment-emergent timeframe (up to 8.5 months) which is the treatment period plus 30 days.","groups":[{"description":"Bortezomib 1.0 mg/m\\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.","id":"OG000","title":"Bendamustine 50 mg/m^2 Cohort"},{"description":"Bortezomib 1.0 mg/m\\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.","id":"OG001","title":"Bendamustine 70 mg/m^2 Cohort"},{"description":"Bortezomib 1.0 mg/m\\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.","id":"OG002","title":"Bendamustine 90 mg/m^2 Cohort"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"up to 8.5 months. Deaths are reported up to 18 months","title":"Summary of Participants With Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"participants"}