DARWIN EU® - Background rates of serious adverse events to contextualise safety assessments in clinical trials and non-interventional studies in adolescent and adult patients with severe asthma

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Asthma
• Additional medical condition(s):
  Severe asthma

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  80000

Study design details

• Main study objective:
  To estimate the mortality rate (all cause and mortality related to infections or cardiovascular events) and the incidence rate of serious cardiovascular events stratified by calendar year, sex, age and country/database during the study period 2015-2022.
• Outcomes:
  Mortality and cause specific mortality namely mortality related to cardiovascular events and mortality related to infections. Serious cardiovascular events consisting of: acute myocardial infarction, acute coronary syndrome/ischemic heart disease, stroke and hospitalisation for heart failure.
• Data analysis plan:
  Annual incidence rate of the outcomes of interest were calculated stratified by country/database, calendar year, age and sex, within the cohort of severe asthma patients. For the calculation of the incidence rate, the numerator was the number of patients newly diagnosed with the respective outcomes of interest and the denominator consisted of the number of person-years of the severe asthma patients fulfilling the inclusion and exclusion criteria at risk. In addition, survival time to all-cause mortality was estimated using Kaplan Meier analysis.

Documents

Study report

DARWIN _EU_D2.2.4_Study_report_P1-C3-001_Severe_asthma_v2.1_Public.pdf