Statistical analysis
TTD
ADVERSE EVENT
All time-to-event outcomes and safety analyses were performed on the full analysis set (FAS) that included all patients receiving at least one dose of osimertinib. The response rate analyses were assessed on the response evaluable set, defined as those patients in the FAS who had at least one documented response assessment by the investigator. Patients who transitioned to a commercial product following national reimbursement were censored at the time of this transition. Time-to-event outcomes (PFS and TTD), including their 95% CIs were estimated using the Kaplan–Meier plot. All AEs and SAEs leading to study drug discontinuation or dose modification were summarized by Medical Dictionary for Regulatory Activities (MedDRA) preferred term (Version 23.1) and Common Terminology Criteria for Adverse Events (CTCAE) class. All statistical analyses were performed using SAS® (SAS Institute, North Carolina) version 9.2 (or later).