Evidence map›Paper›PMID 40970937›Full record

ArticleDie Ophthalmologie2025

[Drug safety and mandatory reporting].

Christian Behles, Robert Hoffmann, Dennis Lex

Abstract readEnglish Abstract
PubMed Publisher
In one paragraph

Article in Die Ophthalmologie, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Christian BehlesBundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland. christian.behles@bfarm.de.
Robert HoffmannBundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.
Dennis LexBundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The spontaneous reporting system for cases of suspected side effects is a central instrument for detecting possible side effects after a pharmaceutical preparation has received marketing authorization. It provides important information (signals) on the occurrence of rare, previously unknown side effects, on increases in the frequency of known side effects that may also be due to quality defects, or on changes in the type or severity of known side effects. In recent decades, this system has made a significant contribution to the identification of drug-related risks that only arise upon widespread use following approval and to the introduction of appropriate measures to minimize risk.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsMandatory ReportingPharmacovigilanceGermanyHumansLegal frameworkPharmaceutical preparations/side effectsPharmacovigilanceSide effects/suspected casesSpontaneous reporting system

Identifiers

PMID40970937

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.