Observational study to investigate safety and effectiveness of lorlatinib as first line treatment for ALK-gene rearranged unresectable advanced/recurrent NSCLC patients in Japan clinical setting

ENCePP Code of conduct

No

Data sources

• Data sources (types):
  Other
• Data sources (types), other:
  Structured and unstructured data from patients’ hospital medical records will be abstracted manually by a trained research associate. Data will subsequently be entered into a study-specific electronic data capture system (EDC) via a standardized electronic case report form (eCRF).

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  Unknown