Long-term Observation PMS for Afatinib

This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as Yes, Probably yes or Can't be denied. The number of patients with Adverse Drug Reactions (ADRs): Malignant progression reported as ADRs were included.

Time frame: From first drug administration until 28 days after the last drug administration, up to 52 weeks.

Population: Safety Set: This analysis set included all patients who had received treatment of GIOTRIF® tablets except those who were found not following registration rules, invalid contract or previous treatment experience with GIOTRIF® tablets.

Objective overall response based on investigator's assessment (according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for target lesions and assessed by MRI: complete response (CR) is the disappearance of all target lesions, a partial response (PR) is defined as at least a 30% decrease in the sum of the target lesion and stable disease (SD) is defined as fitting the criteria neither for progressive disease (PD) nor a PR. The population included the Tyrosine Kinase Inhibitor \[TKI\]-naïve patients and the TKI pre-treated patients. Overall response was calculated with 95% Clopper-Pearson confidence interval. OR = (CR+PR)/(CR+PR+SD+PD+Unknown)\*100.

Time frame: 52 weeks.

Population: Efficacy Set: This analysis set was a subset of the safety set, which included all patients in the safety set except those who had no available tumour assessment and/or who did not suffer from Epidermal Growth Factor Receptor (EGFR) mutation-positive inoperable or recurrent Non-Small Cell Lung Cancer (NSCLC).