Status: Ongoing First registered on: 14/03/2023
Last updated on: 29/03/2023
1. Study identification
EU PAS Register NumberEUPAS103936
Official titleDARWIN 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 title acronym
Study typeObservational study
Brief description of the studyDuring the evaluation of the safety results of a clinical trial in patients with severe asthma, differences in rates of serious adverse events were observed in the experimental treatment arm compared to the control arm. In order to contextualize these differences, a non-interventional study was requested to generate background rates of selected health outcomes in patients with severe asthma, with a disease definition that follows recently conducted clinical trials. By means of a retrospective cohort study using routinely-collected health data from 5 databases we will investigate the following: (i) To estimate the rate of mortality due to any cause stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2021), sex, age and country/database. (ii) To estimate the rate of mortality due to fatal infections stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2021), sex, age and country/database. (iii) To estimate the rate of mortality due to cardiovascular events stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2021), sex, age and country/database . (iv) To estimate the incidence rate of serious cardiovascular events (but not necessarily leading to death) stratified by calendar year as well as pre-pandemic (2015-2019) and pandemic (2020-2021), sex, age and country/database. The study population will consists of all individuals present in the database in the period between 01/01/2015 and 31/12/2021, with at least 1 year of prior history, being diagnosed with severe asthma and fulfilling inclusion and exclusion criteria. The study period is from 2015-2021. Variables of interest will consist of outcomes, comorbidity, lifestyle factors, measurements and drug exposure data. Participating databases have their data mapped to the OMOP CDM. Participating databases are SIDIAP, IPCI, CPRD Gold, IMASIS and the Estonian Biobank.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre nameDARWIN EU CC
Centre locationRotterdam, The Netherlands
Details of (Primary) lead investigator
Title Dr
Last name Verhamme
First name Katia
Is this study being carried out with the collaboration of a research network?
Yes

DARWIN EU CC
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

IDIAPJGol
Health Data Science
PSMAR, Spain
University of Tartu, Estonia
Oxford University, UK
Countries in which this study is being conducted
International study

Estonia
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/12/202219/12/2022
Start date of data collection01/01/201501/01/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report01/05/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Verhamme
First name Katia
Address line 1Dr. Molewaterplein 40
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands
Phone number (incl. country code)31107044129 
Alternative phone number 
Fax number (incl. country code) 
Email address k.verhamme@erasmusmc.nl
Public Enquiries
Title Dr 
Last name Verhamme 
First name Katia 
Address line 1Dr. Molewaterplein 40 
Address line 2 
Address line 3 
CityRotterdam 
Postcode3015 GD 
CountryNetherlands 
Phone number (incl. country code)31107044129 
Alternative phone number 
Fax number (incl. country code) 
Email address k.verhamme@erasmusmc.nl 
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