{"groups":[{"description":"Randomized participants received Osimertinib 80 mg orally once daily (QD)","id":"FG000","title":"Osimertinib 80 mg (Global Cohort)"},{"description":"Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.","id":"FG001","title":"SoC EGFR-TKI (Global Cohort)"},{"description":"Randomized participants received Osimertinib 80 mg orally once daily (QD)","id":"FG002","title":"Osimertinib 80 mg (China Cohort)"},{"description":"Randomized participant received Standard of care (SoC) Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFRTKI). Participants received gefitinib 250 mg orally QD or erlotinib 150 mg orally QD.","id":"FG003","title":"SoC EGFR-TKI (China Cohort)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"2"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"52"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"4"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"}],"type":"Severe non-compliance to protocol"},{"reasons":[{"groupId":"FG000","numSubjects":"153"},{"groupId":"FG001","numSubjects":"199"},{"groupId":"FG002","numSubjects":"39"},{"groupId":"FG003","numSubjects":"56"}],"type":"Condition under investigation worsened"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"0"}],"type":"Any reason not specifically recorded"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"279"},{"comment":"183 participant received gefitinib and 93 participants received erlotinib.","groupId":"FG001","numSubjects":"277"},{"comment":"There were 12 participants who were in both the Global and China Extension Osimertinib Arm.","groupId":"FG002","numSubjects":"71"},{"comment":"There were 7 participants who were in both the Global and China Extension SoC EGFR-TKI Arm.","groupId":"FG003","numSubjects":"65"}],"comment":"There were 19 participants double counted which shows the total participants of 692.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"61"},{"groupId":"FG001","numSubjects":"13"},{"groupId":"FG002","numSubjects":"15"},{"groupId":"FG003","numSubjects":"3"}],"comment":"Participants ongoing study treatment at data cut-off","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"218"},{"groupId":"FG001","numSubjects":"264"},{"groupId":"FG002","numSubjects":"56"},{"groupId":"FG003","numSubjects":"62"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"During the 28 day screening period, participants were enrolled based on the presence in their tumour of at least 1 of the 2 most frequent Epidermal growth factor receptor (EGFR) mutations. At the time of enrolment, all participants were required to provide biopsy tissue for central testing of the Exon 19 deletion (Ex19del) and L858R mutations","recruitmentDetails":"A total of 556 participants in Global cohort (out of 673 participants in Global and China cohorts) were randomized to treatment at 132 study centres in 29 countries. An additional 117 participants in 19 centres were enrolled into the China extension cohort only."}