Adverse drug reactions after administration of medication
Conditions
Interventions
Group 1: Retrospective analysis of spontaneous reports of adverse drug reactions with or without medication error from the EudraVigilance database for adults in Germany between 2012 and 2023.
Group 2:
Sponsors
Bundesinstitut für Arzneimittel und Medizinprodukte
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Case reports from Germany, retrospective data analysis: EudraVigilance data: 01/01/2012 – 31/12/2023 Routine data from the Central Institute for Statutory Health Insurance Physicians (Zi): 01/01/2013 – 31/12/2023 AMTS-FS data: 01/01/2013 – 31/12/2024 ADRED study data: Phase 1: 15/11/2014 – 31/12/2018; Phase 2: 01/01/2019 – 31/03/2022 Electronic health records data: 2020 – 2025
Exclusion criteria
Exclusion criteria: Reports related to vaccines Duplicates in case reports across study arms ADR reports involving suicidal intent, self-harm, intentional overdose, or accidental exposure Parent-Child cases with respect to teratogenicity and consequences for the child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of the study is the characterisation of risk constellations for ADR and ME in adults in Germany with a special focus on polymedicated patients, older patients and severe ADR to enable a conclusion on risk associations and the cause of ADR and ME. Quantifying data regarding frequency, seriousness and risk factors of ADR and ME in the real-world setting in Germany shall be generated and results in the form of key facts shall be recorded as foundation for recommended action. | — |
Countries
Germany
Contacts
Public ContactBernhardt Sachs
Bundesinstitut für Arzneimittel und Medizinprodukte
Outcome results
None listed