{"groups":[{"description":"Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.","id":"FG000","title":"Part A: JZP-458 IM 25 mg/m^2 (MWF)"},{"description":"Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.","id":"FG001","title":"Part A: JZP-458 IM 37.5 mg/m^2 (MWF)"},{"description":"Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\\^2 on Mondays and Wednesdays and 50 mg/m\\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.","id":"FG002","title":"Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)"},{"description":"Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\\^2 on Mondays and Wednesdays and 50 mg/m\\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.","id":"FG003","title":"Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"12"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"0"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by parent or guardian"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Withdrawal by participant"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"83"},{"groupId":"FG002","numSubjects":"51"},{"groupId":"FG003","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"83"},{"groupId":"FG002","numSubjects":"51"},{"groupId":"FG003","numSubjects":"0"}],"type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"32"},{"groupId":"FG001","numSubjects":"83"},{"groupId":"FG002","numSubjects":"50"},{"groupId":"FG003","numSubjects":"0"}],"type":"Efficacy Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"62"},{"groupId":"FG002","numSubjects":"39"},{"groupId":"FG003","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Part A"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"21"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"7"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Recurrent disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"3"}],"type":"Withdrawal by parent or guardian"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Withdrawal by participant"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"62"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"61"}],"type":"Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"59"}],"type":"Efficacy Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"27"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"35"}],"type":"NOT COMPLETED"}],"title":"Part B"}],"recruitmentDetails":"A total of 229 participants who met all inclusion and no exclusion criteria were enrolled in the study. One participant did not receive treatment; 228 participants were included in the Safety Analysis Set and 224 participants were included in the Efficacy Analysis Set. The data presented are based on the final database cut (22 November 2022)."}