PHARMACOVIGILANCE IN JUVENILE IDIOPATHIC ARTHRITIS PATIENTS (PHARMACHILD) TREATED WITH BIOLOGIC AGENTS AND/OR METHOTREXATE.

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.

Disease details

Disease details, other

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.

Pregnancy and/or neonates

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

Hospital admission and/or discharge

ICU admission

Is information on intensive care unit admission available?

Cause of death

Prescriptions of medicines

Prescriptions vocabulary

Prescriptions vocabulary, other

Dispensing of medicines

Advanced 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)].

Contraception

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

Indication for use

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

Medical devices

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

Administration of vaccines

Procedures

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

Procedures vocabulary

Clinical measurements

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

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.

Genetic data

Are data related to genotyping, genome sequencing available?

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.

Patient-reported outcomes

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

Patient-generated data

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

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.

Unique identifier for persons

Are patients uniquely identified in the data source?

Diagnostic codes

Diagnosis / medical event vocabulary

Medicinal product information

Medicinal product information collected

Medicinal product vocabulary

If 'other,' what vocabulary is used?

Quality of life measurements

Quality of life measurements vocabulary

Quality of life measurements, other

Lifestyle factors

Sociodemographic information

Sociodemographic information collected