Spanish Real World Data on unresectable stage III NSCLC patients treated with durvalumab after chemoradiotherapy (S-REAL Study)

ENCePP Code of conduct

No

Data sources

• Data source(s):
  Other data source
• Data source(s), other:
  The source of information will be, the medical history of the patient regarding the treatments received before and within the Spanish Expanded Access Program (EAP) of Durvalumab.
• Data sources (types):
  Other
• Data sources (types), other:
  The sample of patients identified for the current study will be based on a portion of patients enrolled into the durvalumab PACIFIC study and no hypothesis and power analysis will be conducted. The study will include all patients who have participated in the PACIFIC study between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

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

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation moment:
  after data extraction
• Data characterisation details:
  Missing values were not considered when calculating percentages or any other descriptive estimator, meaning; that only valid values are presented. No methods for handling missing data were used. The analysis was performed; using IBM SPSS Statistics software, Version 26.0 (IBM Corp. Armonk, NY).