Safety registry for Eurartesim

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:
  Cohort

Study drug and medical condition

• Name of medicine:
  EURARTESIM
• Medical condition to be studied:
  Malaria

Population studied

• Short description of the study population:
  Any patient with malaria who is treated with Eurartesim.; The following patients were included in the registry:; - Diagnosed with malaria (Plasmodium falciparum); diagnosis were clinically and parasitologically confirmed.; - Prescribed EurartesimTM treatment on the day on enrolment.; - Have been informed, provide consent to participate in this registry and sign the Informed Consent Form (ICF).
• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Malaria patients
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The primary objective is to evaluate the association between safety parameters (in particular QTc prolongation) and the following - age, gender, ethnicity, lifestyle, food intake, co-medications and co-morbidities.
• Outcomes:
  The main focus of the statistical analysis is the assessment of the association between safety parameters (in particular QTc prolongation) and determinant factors. For QTc prolongation (Fredericia correction) and relevant laboratory parameters will be assessed via regression analysis. different transformations will be used to normalise the data if required. Assessment of AESI and QTc will be done. A descriptive analysis of the QTc data (absolute values, changes from baseline to day 3) using both Bazett (QTcB) and Fredericia (QTcF) corrections and laboratory values will be done. Descriptive statistics relating to the basic efficacy data will be presented. The incidence of all AEs and SAEs will be estimated and incidences of cardiac events, AESI and SAEs presented overall and by variable.
• Data analysis plan:
  Continuous variables will be described by their mean, SD, median, quartile 1 and 3, extreme values and number of missing data. Categorical variables will be described by the total and % of each response method and the number of missing data. Continuous variables will be compared between subgroups using Students t-test or variance analysis. if the conditions for applying these tests are not met, Mann-Whitney, Wilcoxon or Kruskal-Wallis non-parametric tests will be used.Categorical variables will be compared between subgroups using the Chi-2 test if the theoretical total of each class studies is greater than 5. Otherwise Fisher's exact test will be used.The ordinal variables will be compared between subgroups using a Cochran-Mantal-Haenszel test.Hypothesis formulation will be bilateral, The tests will be performed for a first species alpha risk of 5%