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Safety of Anthroposophic Medicinal Products

Safety of Anthroposophic Medicinal Products in Manufacturers' Pharmacovigilance Database

Status
Recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON27242
Enrollment
Unknown
Registered
2018-09-24
Start date
2018-11-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

safety, adverse events, anthroposophical medicinal products, pharmacovigilance

Interventions

Anthroposophic medicinal products

Sponsors

Institute for Applied Epistemology and Medical Methodology (IFAEMM) Zechenweg 6 D-79111 Freiburg, Germany Tel:+49 761 1560305 Fax: +49 (0)761-1560306 email: anja.glockmann@ifaemm.de and Louis Bolk Institute Kosterijland 3-5 3981 AJ Bunnik info@louisbolk.nl tel. +31(0)343 523.860 fax +31(0)343 515.611
Lead Sponsor

Eligibility

Inclusion criteria

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 - Non-serious and serious ADRs - ADRs from Anthroposophic Medicinal Products (AMPs) sold in Germany - ADRs from post-marketing surveillance and clinical/safety trials - ADRs that are assessed by the responsible person within the company (causal relationship with respect to drug administration is described) - Spontaneous reports by consumers/patients, health professionals - Literature cases

Exclusion criteria

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 - ADRs from medicinal products with active ingredients which are not prepared according to the Anthroposophic Pharmaceutica Codex (APC)

Design outcomes

Primary

MeasureTime frame
The frequency of reported ADRs relative to the total sales volume of AMPs.—

Secondary

MeasureTime frame
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.—

Contacts

Public ContactErik Baars
baars.e@hsleiden.nl0031 71 5188715

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)