A descriptive study of potential sight threatening event and severe visual loss following exposure to XALKORI (crizotinib)

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
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive, Non-interventional, enhanced Pharmacovigilance, global study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CRIZOTINIB
• Medical condition to be studied:
  Non-small cell lung cancer

Population studied

• Short description of the study population:
  To be eligible for the study, patients must have been treated with crizotinib and have AE/SAE reports indicative of Potential Sight-threatening Event (PSTE)/Severe Visual Loss (SVL) received from study data sources between March 31, 2016 and March 31, 2021. All reports indicative of PSTE/SVL in patients that have been treated with crizotinib are included, regardless of the indication for use of crizotinib. This will allow for comprehensive analysis of PSTE/SVL cases for the study.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  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:
  Other
• Special population of interest, other:
  Non-small cell lung cancer patients
• Estimated number of subjects:
  50

Study design details

• Main study objective:
  The objective of the study is to evaluate the frequency of risk factors for and sequelae of Potential sight threatening event (PTSE)/Severe visual loss (SVL) following exposure to crizotinib
• Data analysis plan:
  The study population will consist of all PSTE/SVL reports received within the study period. All statistical analyses will be descriptive. Demographics and clinical characteristics will be tabulated. Risk factors for and outcomes of PSTE/SVL will be described and summarized overall, by grade or by indication as appropriate. Frequencies and percentages will be presented for categorical variables. For continuous variables, means, standard deviations, and ranges, or medians and inter quartile ranges, will be reported as appropriate. Detailed methodology for summary of data collected in this study will be documented in a Statistical Analysis Plan (SAP), which will be dated, filed and maintained by the sponsor. The SAP may modify the plans outlined in the protocol, any major modifications of the protocol would be reflected in a protocol amendment.

Documents

Study results

a8081062-report-body

Study report

a8081062-abstract

A8081062-first-interim-report

Study, other information

A8081062-first-interim-report.pdf