{"groups":[{"description":"Patient injected with OTL38 and undergoes near infrared imaging.\n\nDrug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes\n\nOther Names:\n\nOTL38 for Injection Device: near infrared camera imaging system Infrared imaging used to excite OTL38 for fluorescence\n\nOther Names:\n\nNear IR imaging Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery","id":"FG000","title":"Experimental: OTL38 Injection and Near Infrared Imaging"},{"description":"Patient injected with OTL38, but does not undergo fluorescent imaging.\n\nDrug: OTL38 0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes\n\nOther Names:\n\nOTL38 for Injection Procedure/Surgery: laparotomy primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery","id":"FG001","title":"Sham Comparator: OTL38 Injection and No Fluorescent Imaging"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}],"type":"Majority of which were disease too extensive and camera not used"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"6"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"16"}],"comment":"All subjects received study drug prior to randomization. A total of 150 subjects received study drug, 10 of which were not randomized to either arm. These 10 subjects withdrew to the study prior to randomization but are included in the Safety Analysis Set.","type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"134"},{"groupId":"FG001","numSubjects":"0"}],"type":"Full Analysis Set/ Intent to Image Set"},{"achievements":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","numSubjects":"0"}],"type":"Per Protocol Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"122"},{"groupId":"FG001","numSubjects":"6"}],"type":"Pharmacokinetic Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"128"},{"groupId":"FG001","numSubjects":"6"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}]}