Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Observational, multi-centre, multi-national, study
Study drug and medical condition

Medicinal product name, other

Cidofovir 75 mg/ml concentrate for solution for infusion, Cidofovir Tillomed 75 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Cidofovir Tillomed 75 mg/ml concentrado para solución para perfusión EFG, Cidofovir Tillomed 75 mg/ml concentraat voor oplossing voor infusie Cidofovir Tillomed 75 mg/ml solution à diluer pour perfusion

Study drug International non-proprietary name (INN) or common name

CIDOFOVIR

Anatomical Therapeutic Chemical (ATC) code

(J05AB12) cidofovir
cidofovir
Population studied

Short description of the study population

Patients prescribed with cidofovir identified from the European countries, including the UK, Belgium, Germany, and Spain for the study period of June 2016 to June 2018.
Inclusion criteria:
• The patient is exposed to Cidofovir (Emcure’s formulation);
• Patient or patient’s authorised carer (in event the patient is unable to consent) is willing to provide written informed consent;
• The patient should have reported exposure or outcomes which are verified by a HCP. Any reported exposure or outcome not verified by a HCP, should exclude the patient from the Cidofovir Exposure Registry.

Age groups

  • 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)
  • 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)

Special population of interest

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

2951
Study design details

Main study objective

To identify the indications and patient populations for the use of Cidofovir, as well as to evaluate patterns and compare rates of adverse events occurring in the on label group with events occurring in the off label group, and to assess the patient outcome following treatment in the specified indication.

Data analysis plan

Patients prescribed Cidofovir for on-label or off label indication will be recorded and monitored to observe frequency of adverse events in the on-label group versus the off-label group. This information will be recorded via a website that the marketing authorisation holder will implement and information can be extracted to analyse these data sets.