{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Arterial thromboembolic events (any grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"}]}],"title":"Bleeding other than pulmonary or CNS (Grade >=3)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Febrile neutropenia (any grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Gastrointestinal Perforation (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"8"}]}],"title":"Hypertension (Grade >= 3)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Left Ventricular Systolic Dysfunction (Grade >= 3)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"10"}]}],"title":"Neutropenia (Grade >= 3)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Osteonecrosis of the Jaw"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"}]}],"title":"Peripheral Neuropathy (Grade >= 3)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"}]}],"title":"Pulmonary and CNS Bleeding (Any Grade)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"15"}]}],"title":"Thrombocytopenia (Grade >= 3)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Vernous Thromboembolic Events (Grade >=3)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"50"}],"units":"Participants"}],"description":"Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0. All serious adverse events are listed in the Adverse Event Reporting section.","groups":[{"description":"Participants received bortezomib 1.3 mg/m\\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.","id":"OG000","title":"BORT + P"},{"description":"Participants received bortezomib 1.3 mg/m\\^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.","id":"OG001","title":"BORT + BV"}],"paramType":"NUMBER","populationDescription":"Safety population: all patients who were randomized and received any amount of study treatment. Two patients who randomized to the BORT + P arm received at least 1 dose of bevacizumab and were analyzed as bevacizumab-treated patients. Therefore, the safety analysis included 50 patients in the BORT + P arm and 50 patients in the BORT + BV arm.","reportingStatus":"POSTED","timeFrame":"Participants were monitored for AEs from initiation of treatment to 30 days after treatment termination (up to 122 weeks).","title":"Number of Participants With Selected Adverse Events (AEs)","type":"SECONDARY","unitOfMeasure":"Participants"}