Safety of Anthroposophic Medicinal Products
Recruiting
- Conditions
- safety, adverse events, anthroposophical medicinal products, pharmacovigilance
- Registration Number
- NL-OMON27242
- Lead Sponsor
- Institute for Applied Epistemology and Medical Methodology (IFAEMM)Zechenweg 6D-79111 Freiburg, GermanyTel:+49 761 1560305Fax: +49 (0)761-1560306email: anja.glockmann@ifaemm.deandLouis Bolk InstituteKosterijland 3-53981 AJ Bunnikinfo@louisbolk.nltel. +31(0)343 523.860 fax +31(0)343 515.611
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Only those Adverse Drug Reactions (ADRs) that are reported in humans
- All valid and suspected ADR reports (including those related to off-label use) filed in the period from 1 January 2010 to 31 December 2017, independent from the ADR reporting duty to the European Medicines Agency
Exclusion Criteria
- ADRs from AMPs sold in countries other than Germany
- ADRs for which the causality is assessed by the company as excluded or unlikely/remote
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The frequency of reported ADRs relative to the total sales volume of AMPs.
- Secondary Outcome Measures
Name Time Method The relative frequency of ADRs to subgroups of AMPs, properties of ADRs such as the seriousness, classification according to system organ class (MedDRA), labelling, outcome, type of report, type of reporter and causality as well as characteristics of ADRs to AMP such as the origin of starting materials, dilution of active ingredients (non-diluted versus D1-D3 versus ¡Ý D4 versus composition of dilutions), route of administration (parenteral versus local, versus oral) and indications.