Vargatef in 2nd-line therapy of advanced or metastatic adenocarcinoma of the lung (VARGADO)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  VARGATEF
• Medical condition to be studied:
  Lung adenocarcinoma

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:
  700

Study design details

• Main study objective:
  Assess 1-year survival rate
• Outcomes:
  Assess 1-year survival rate, Assess 1-year progression-free survival rate in patients with early progression of first-line therapy. Median overall survival. Median progression free survival. Tumor controll rate. Duration of therapy and modifications. Incidence of adverse events related to Vargatef
• Data analysis plan:
  All analyses are descriptive, SAS software will be used. Frequency tables for categorial variables will depict all possible categories and will report the number of observations and the percentage per characteristic feature. The number of patients with missing values and the percentage of the total patient population will also be presented (if necessary).All analyses are presented in the overall population. These analyses are also performed additionally according to further subgroups in the event of special interests. The details of the statistical analyses are described in the statistical analysis plan (TSAP) which is produced in a completed form before database lock.The main diagnosis must be met. The primary endpoint of this NIS is the survival rate one year after the beginning of treatment with Vargatef® + docetaxel. Relative frequency of patients who have not died after 12 months will be presented, together with the 95% confidence interval.