The data source contains the following information

Disease information

Does the data source collect information with a focus on a specific disease? This might be a patient registry or other similar initiatives.

Yes

Rare diseases

Are rare diseases captured? In the European Union a rare disease is one that affects no more than 5 people in 10,000.

Yes

Pregnancy and/or neonates

Does the data source collect information on pregnant women and/or neonatal subpopulation (under 28 days of age)?

Yes

Hospital admission and/or discharge

Yes

ICU admission

Is information on intensive care unit admission available?

Yes

Cause of death

Captured

Cause of death vocabulary

MedDRA

Prescriptions of medicines

Captured

Prescriptions vocabulary

not coded

Dispensing of medicines

Not Captured

Advance therapy medicinal products (ATMP)

Is information on advanced therapy medicinal products included? A medicinal product for human use that is either a gene therapy medicinal product, a somatic cell therapy product or a tissue engineered products as defined in Regulation (EC) No 1394/2007 [Reg (EC) No 1394/2007 Art 1(1)].

No

Contraception

Is information on the use of any type of contraception (oral, injectable, devices etc.) available?

Yes

Indication for use

Does the data source capture information on the therapeutic indication for the use of medicinal products?

Not Captured

Medical devices

Is information on medicinal devices (e.g., pens, syringes, inhalers) available?

No

Administration of vaccines

Yes

Procedures

Does the data source capture information on procedures (e.g., diagnostic tests, therapeutic, surgical interventions)?

Captured

Procedures vocabulary

MedDRA

Clinical measurements

Is information on clinical measurements (e.g., BMI, blood pressure, height) available?

Yes

Healthcare provider

Is information on the person providing healthcare (e.g., physician, pharmacist, specialist) available? The healthcare provider refers to individual health professionals or a health facility organisation licensed to provide health care diagnosis and treatment services including medication, surgery and medical devices.

Yes

Genetic data

Are data related to genotyping, genome sequencing available?

Not Captured

Biomarker data

Does the data source capture biomarker information? The term “biomarker” refers to a broad subcategory of medical signs ( objective indications of medical state observed from outside the patient), which can be measured accurately and reproducibly. For example, haematological assays, infectious disease markers or metabolomic biomarkers.

Captured

Biomarker data vocabulary

Other

Biomarker vocabulary, other

Laboratory values, free text

Patient-reported outcomes

Is information on patient-reported outcomes (e.g., quality of life) available?

Yes

Patient-generated data

Is patient-generated information (e.g., from wearable devices) available?

Yes

Units of healthcare utilisation

Are units of healthcare utilisation (e.g., number of visits to GP per year, number of hospital days) available or can they be derived? Units of healthcare utilisation refer to the quantification of the use of services for the purpose of preventing or curing health problems.

No

Unique identifier for persons

Are patients uniquely identified in the data source?

Yes

Diagnostic codes

Captured

Diagnosis / medical event vocabulary

MedDRA

Medicinal product information

Captured

Medicinal product information collected

Brand name
Dosage regime

Medicinal product vocabulary

Not coded (Free text)

Quality of life measurements

Captured

Quality of life measurements vocabulary

other

Quality of life measurements, other

HAQ

Lifestyle factors

Captured

Lifestyle factors collected

Alcohol use
Tobacco use

Sociodemographic information

Captured

Sociodemographic information collected

Age
Education level
Gender
Marital status