Product identification of biologicals in ADR reports received from European clinical practice

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assess quality of ADR reports in EudraVigilance
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EPOETIN ALFA

  ETANERCEPT

  INFLIXIMAB

  HUMAN NORMAL IMMUNOGLOBULIN

  INTERFERON BETA-1A

  INSULIN GLARGINE

  FILGRASTIM

  OCTOCOG ALFA

  SOMATROPIN

  FOLLITROPIN ALFA

Population studied

• Short description of the study population:
  The study explored identifiability and traceability of biologicals in spontaneous ADR reports received from the European clinical practice between January 2011 and June 2016.
• 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)
• Estimated number of subjects:
  999999

Study design details

• Main study objective:
  To assess the level of precise identification of biologicals up to the product level in ADR reports received from European clinical practice
• Outcomes:
  The product identification – the extent to which a single reported product is traceable up to the specific manufacturer – will be determined for each reported biological, Batch traceability, differences in ADR reporting patterns between similar and related products
• Data analysis plan:
  The number and percentage of precise product identification will be calculated for all reported biologicals, and results will be stratified according to the biological category (innovator, biosimilar, related biological product), the product class, the drug role code (suspected/ concomitant), and primary reporting source. In addition, the overall batch traceability may be explored for the reported biologicals, including the temporal trends herein, and factors determining the traceability. Lastly, ADR reporting patterns (e.g. case characteristics, including type of and seriousness of ADRs, temporality of reporting, etc.) may be compared between similar and reference products.

Documents

Study publications

Vermeer NS, Giezen TJ, Zastavnik S, Wolff‐Holz E, Hidalgo‐Simon A. Identi