{"groups":[{"description":"Participants were treated with E7777 6 mcg/kg by intravenous (IV) infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.","id":"FG000","title":"Lead-In Part: E7777 6 mcg/kg"},{"description":"Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.","id":"FG001","title":"Lead-In Part: E7777 9 mcg/kg"},{"description":"Participants were treated with E7777 12 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-in part.","id":"FG002","title":"Lead-In Part: E7777 12 mcg/kg"},{"description":"Participants were treated with E7777 15 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Lead-In Part.","id":"FG003","title":"Lead-In Part: E7777 15 mcg/kg"},{"description":"Participants were treated with E7777 9 mcg/kg by IV infusion over 60 minutes on 5 consecutive days in 21-day cycles for up to 8 cycles or disease progression or unacceptable toxicity in Main study part.","id":"FG004","title":"Main Study Part: E7777 9 mcg/kg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Disease Progression"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"The primary efficacy analysis set was defined as participants who had Stage I to III Cutaneous T-Cell Lymphoma (CTCL) at baseline and received E7777 at 9 mcg/kg; this set included 64 participants from the Main Study and 5 participants from the Lead-In part- this set had total 69 participants.","groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"Primary Efficacy Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"4"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Lead-In Part (1 Year 2 Months)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"11"}],"type":"Sponsor Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"20"}],"type":"Disease progression"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"1"}],"type":"Not treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"91"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"comment":"The primary efficacy analysis set was defined as participants who had Stage I to III Cutaneous T-Cell Lymphoma (CTCL) at baseline and received E7777 at 9 mcg/kg; this set included 64 participants from the Main Study and 5 participants from the Lead-In part- this set had total 69 participants.","groupId":"FG004","numSubjects":"64"}],"type":"Primary Efficacy Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"46"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"45"}],"type":"NOT COMPLETED"}],"title":"Main Study Part (2 Years 4 Months)"}],"preAssignmentDetails":"36 participants were screened in Lead-In Part, out of which 21 were enrolled and treated.143 participants were screened in Main Study Part, out of which 91 were enrolled and 90 were treated. As per planned analysis, data was collectively reported for total 98 participants (Full analysis set/Safety analysis set) from Main Study Part and Lead-In Part who received study drug at 9 micrograms per kilograms (mcg/kg) dose. 8 participants were from Lead-In Part and 90 were from Main Study Part.","recruitmentDetails":"Participants took part in the study at 20 investigative sites in the United States and Australia from 30 May 2013 to 14 December 2021."}