Study type

Study topic

Disease /health condition

Study type

Non-interventional study

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
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.