DARWIN EU® - Characteristics of individuals with acute graft vs. host disease with intestinal involvement

Study type

• Study topic:
  Disease /health condition
• 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 graft versus host disease

  Acute graft versus host disease in intestine

Population studied

• Short description of the study population:
  Inclusion criteria: ; For objective 1, the study population will consist of all individuals with at least 365 days of database history, a diagnosis with aGvHD or aGvHD with intestinal involvement, and with a minimum age of 18 years at time of diagnosis. ; Exclusion criteria:; • Individuals with a history of aGvHD prior to the start of the study period; • Less than 365 days of database history prior to the index date;
• 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:
  A cohort study will be conducted using routinely collected health data from 3 data sources from 3 countries across Europe.
• Main study objective:
  1. Describe the baseline characteristics (age, sex, transplant type, indication of transplant, treatment (corticosteroids, ruxolitinib, and other second line treatment for aGvHD), and mortality) of patients with aGvHD.; 2. Describe the baseline characteristics (age, sex, transplant type, indication of transplant, treatment (corticosteroids, ruxolitinib, and other second line treatment for aGvHD), and mortality) of patients with aGvHD with intestinal involvement.
• Outcomes:
  Mortality will be assessed in three time windows following index date, both in the aGvHD and aGvHD with ; intestinal involvement cohort (irrespective of treatment) ; These windows are: ; o In the window from index date (day 0) to 30 days following index date ; o In the window from 31 days up to 90 days following index date ; o In the window from 91 to 365 days following index date