Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L01XE29) lenvatinib
lenvatinib

Medical condition to be studied

Hepatocellular carcinoma
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

1000
Study design details

Main study objective

To further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (HCC) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events SAEs, grade 3 to 5 adverse events AEs, dose modifications and discontinuations due to AEs) in participants with advanced or unresectable HCC treated with lenvatinib.

Outcomes

1. Number of Participants With Hepatotoxicity Treatment-emergent Adverse Events (TEAEs) With Lenvatinib
2. Number of Participants With SAEs With Lenvatinib
3. Number of Participants With Grade 3 to 5 AEs With Lenvatinib
4. Number of Participants with one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations of Lenvatinib, Duration of lenvatinib treatment, the incidence of dose interruptions and dose reductions, the relative dose intensity of lenvatinib, treatment sequencing following lenvatinib treatment. Overall survival. Treatment patterns in patients treated with sorafenib. The association of patient demographic and baseline disease-related characteristics to treatment decisions.

Data analysis plan

This study is descriptive and primarily aims to further characterise hepatotoxicity and overall safety profile in patients with advanced or unresectable HCC treated with lenvatinib.
Study results will be summarised separately by treatment cohort (i.e. lenvatinib or sorafenib) and treatment line, without pre-defined hypotheses. Categorical variables will be reported as counts (n) and frequencies (%). Continuous variables will be reported using mean, standard deviation, median, interquartile range (Q1 to Q3), and range.
Descriptive analyses (including standard univariate analyses) will be conducted to evaluate demographic and clinical characteristics, crude incidence proportions, and rates of prespecified hepatotoxic events.
Time-to-event outcomes (e.g. OS) will be assessed using the Kaplan-Meier method and will be reported as descriptive statistics.