{"groups":[{"description":"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.\n\nMaintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.\n\nReinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose.","id":"FG000","title":"PS-341"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"18"}],"type":"Lack of Efficacy"},{"reasons":[{"groupId":"FG000","numSubjects":"7"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"4"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"other complicating disease"},{"reasons":[{"groupId":"FG000","numSubjects":"4"}],"type":"other"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"missing data"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Ineligible"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"never start protocol therapy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"44"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"43"}],"type":"Eligible"},{"achievements":[{"groupId":"FG000","numSubjects":"42"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"42"}],"type":"Induction Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"15"}],"type":"Maintenance Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"7"}],"type":"Reinduction Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"1"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"43"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"The study was activated on January 16, 2004 and terminated on March 7, 2005 after 44 patients had enrolled. Accrual rate was 3 patients per month, slower than expected rate (6 patients per month)"}