DARWIN EU® - Acute myeloid leukaemia: incidence, patient characteristics, treatments, and survival in the period 2015–2024

Study type

• Study topic:
  Disease /health condition
• Study topic, other:
  Acute myeloid leukaemia
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Acute myeloid leukaemia

Population studied

• Short description of the study population:
  For the estimation of incidence, all individuals present in the data source will be included in the denominator according to the requirements described in section 8.4 of the protocol. Only individuals with newly diagnosed AML will be included in the study for objectives 2–4.; Objective 1 inclusion criteria; • Observation in the period 01/01/2015 to 31/12/2024 ; • Minimum 365 days of available history before contributing to person-time at risk (except for children <1 year); Objective 2–4 inclusion criteria; • First diagnosis of AML in the period of 01/01/2015 to 31/12/2024 ; • Minimum 365 days of available history before diagnosis date (except for children <1 year); • No prior history of AML before the study period;
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • 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)

Study design details

• Study design:
  Cohort studies will be conducted using routinely collected health data
• Main study objective:
  1. To estimate the annual incidence of AML in children (<18 years old) and adults (≥18).; 2. To characterise AML patients in terms of demographics, performance status, conditions, disease characteristics, measurements, and procedures.; 3. To describe treatment patterns in AML patients.; 4. To estimate overall survival 1, 3, and 5 years for patients with newly diagnosed AML.;