GIOTRIF rPMS in Korean Patients With NSCLC

Percentage of participants with Adverse Drug Reactions (ADRs).

Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.

Population: All Participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 1 subject was excluded from the set based on disease indication.

Overall Survival (OS), defined as time from the date of the first administration of afatinib to the date of death. Kaplan-Meier estimates and 95% confidence intervals for the 25th, median, and 75th percentiles of the survival distribution will be calculated for OS. For patients with known date of death: OS \[days\] = date of death - (date of start of treatment) + 1 For patients known not death case: OS (censored) \[days\] = date of last contact showing no death - (date of start of treatment) + 1.

Time frame: From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.

Population: Effectiveness assessment set: all participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 221 subjects were excluded due to missing effectiveness assessments.

Best response is defined as the best response observed in individual subject from the date of the first administration of the study medication until the earliest recording of Progressive disease (PD), death, or end of treatment (as long as no additional anti-cancer therapy was implemented). Disease Assessment will be based on the assessment of cancer related symptoms and, if available, radiologic assessments as per standard of care at the site. Tumour response according to investigator's assessment Each patient will be assigned to one of the following categories: 1. Complete response (CR) 2. Partial response (PR) 3. Stable disease (SD) 4. Progressive disease (PD) 5. Not evaluable for response, reasons to be specified (e.g. early death, tumour assessments incomplete, etc.)

Time frame: Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.

Population: Effectiveness assessment set: all participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 221 subjects were excluded due to missing effectiveness assessments, an additional 36 subjects were excluded for not completing the assessment at the last visit.

Progression-Free Survival (PFS) rate, defined as the percentage of patients who were alive and without disease progression at the 48-week tumour assessment. Progression was assessed by the investigator according to local standard pattern of care for non-small cell lung cancer (NSCLC). If a patient is known to have progressed, but the date of progression is not attainable, the last date when the patient was assessed will be used as date of progression. PFS rate at 48 weeks was estimated using Kaplan-Meier estimates on the PFS curve.

Time frame: From week 0 until week 48. Up to 48 weeks.

Population: Effectiveness assessment set: all participants whose case report forms (CRFs) were retrieved during the re-examination period (29 Jan 2014 - 28 Jan 2020) and who did not violate the inclusion/exclusion criteria. 221 subjects were excluded due to missing effectiveness assessments.