A multinational active safety surveillance study of crizotinib in Europe and the United States

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Active surveillance of existing databases

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CRIZOTINIB

  ERLOTINIB

  GEFITINIB

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

Population studied

• Short description of the study population:
  Patients who were diagnosed with primary lung cancer and receive dispensation/prescription for crizotinib, ceritinib, erlotinib, or gefitinib as recorded in national or regional health care databases in Denmark, Finland, the Netherlands, Sweden, and the US from September 1st , 2011 to June 30th, 2017. In addition, all other cancer patients receiving crizotinib dispensation/prescription were included.
• 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)
• Special population of interest:
  Hepatic impaired

  Renal impaired
• Estimated number of subjects:
  2683

Study design details

• Main study objective:
  The main objective of this study is to evaluate the safety and effectiveness of crizotinib among ALK positive NSCLC patients in the real world setting. Safety and effectiveness will be measured with data from pre-existing European and US databases, and these data will be validated with information e
• Outcomes:
  To estimate the incidence rate and incidence proportion over a 3-year period of observation for hepatotoxicity, pneumonitis/ILD, QTc prolongation related events, bradycardia, and visual disorders among lung cancer patients receiving crizotinib dispensation. To estimate the incidence of the primary endpoints for lung cancer patients receiving ceritinib/erlotinib/gefitinib dispensation, To estimate the incidence of renal cysts, edema, leukopenia, neuropathy, and photosensitivity among lung cancer patients receiving crizotinib, ceritinib, erlotinib, or gefitinib dispensation,To estimate Kaplan-Meier survival probabilities for patients in the study.
• Data analysis plan:
  This study will link existing national or regional databases within Sweden, Denmark, the Netherlands, Finland, and the United States. Demographics, tumor characteristics, pertinent medical history, comorbidities, safety outcomes of interest, and overall patient survival will be examined.All statistical analyses will be descriptive. Incidence rates and incidence proportions for all study endpoints will be calculated. Subgroup analyses by age, presence or absence of brain metastases, and pre-existing renal or hepatic impairments at baseline will be conducted for all primary study endpoints. Kaplan-Meier survival probability will be estimated for all patients. In addition, sensitivity, specificity and positive predictive value (PPV) of primary study endpoints captured using ICD codes (compared to patient medical records) will be calculated.

Documents

Study report

A8081038 NI Study Report

Crizotinib A8081038 Second Interim Report Synopsis_21 Sept 2016

Study, other information

Crizotinib A8081038 Second Interim Report Synopsis_21 Sept 2016.pdf