Brigatinib-5007: A Cohort Study to Describe the Occurrence of Early-Onset Pulmonary Events in Patients with Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Treated with Brigatinib: A Post-Authorisation Safety Study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BRIGATINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01XE43) brigatinib

  brigatinib
• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  180

Study design details

• Main study objective:
  The primary objective of the study is to describe the occurrence of EOPEs in ALK positive advanced NSCLC patients treated with brigatinib in real-world practice.
• Outcomes:
  The primary outcomes will assess the occurrence of adjudicated EOPEs occurring within 14 days after the initiation of brigatinib. The secondary outcome will include the success rate of Patient Alert Card.
• Data analysis plan:
  Descriptive statistics will be used which comprise the number of observations, mean, standard deviation, median, minimum, and maximum for continuous variables, as well as number and percent for categorical variables. The association of potential risk factors with EOPEs will be evaluated by univariable logistic regression models and will be quantified using odds ratios with 95 percent (%) confidence intervals.

Documents

Study results

Brigatinib-5007_CSR Synopsis_09-Sep-2024.pdf