Evidence map›Paper›PMID 39858904›Full record

ArticleMicroorganisms2025

A Comprehensive 10-Year Nationwide Pharmacovigilance Surveillance on Antibacterial Agents in Korea: Data Mining for Signal Detection of Trends and Seriousness of Adverse Events.

Seon Hu Mo, Soo Hyeon Lee, Chang-Young Choi, Yongjun Sunwoo, Sooyoung Shin, Yeo Jin Choi

Abstract read
In one paragraph

Article in Microorganisms, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

6 authors.

Seon Hu MoDepartment of Pharmaceutical Science, College of Pharmacy, Kyung Hee University, Seoul 02447, Republic of Korea.
Soo Hyeon LeeDepartment of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of Korea.
Chang-Young ChoiDepartment of Gastroenterology, Korea Medical Institute, Suwon 16553, Republic of Korea.
Yongjun SunwooDepartment of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of Korea.
Sooyoung ShinDepartment of Pharmacy, College of Pharmacy, Ajou University, Suwon 16499, Republic of Korea.ORCID 0000-0003-2388-1122
Yeo Jin ChoiDepartment of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of Korea.ORCID 0000-0002-0635-4374

Funding

Ministry of Education 2021R1I1A1A01044500Ministry of Food and Drug Safety 21153MFDS 601Ministry of Science and ICT 2021R1C1C1003735
6 · The paper itself

Abstract

A comprehensive pharmacovigilance surveillance on antibacterials is lacking. This study aims to investigate safety signals of antibacterial-related adverse drug events (ADEs) with seriousness and to identify predictors of serious ADEs. This study investigated 52,503 antibacterial-induced ADEs reported to the Korea Adverse Event Reporting System Database from January 2013 to December 2022. Disproportionality analysis was conducted, and the effect sizes were estimated by reporting odds ratios (ROR), proportional reporting ratio (PRR), and information component (IC). Multivariate logistic regression was performed to investigate the predictors of serious ADEs by estimating the odds ratio (OR). Serious events were more likely to be cardiovascular disorders (ROR 6.77, PRR 6.6, IC 2.37), urinary system disorders (ROR 5.56, PRR 5.22, IC 2.12), and platelet, bleeding, and clotting disorders (ROR 5.41, PRR 5.17, IC 2.06). The predictors may include age (OR 1.05), the number of concomitant medications (OR 1.44), concomitant proton pump inhibitors (OR 1.46) and non-steroidal anti-inflammatory drugs (OR 1.38) use, and specific antibacterial classes, while multiple antibacterial therapy was associated with lower serious ADE risks. The sensitivity analysis also suggests the male sex (OR 1.18) as a potential predictor of serious ADEs. However, further studies are imperative to determine the causality of antibacterial-induced ADEs in critically ill patients.

Indexed as

antibacterialbacterial infectiondrug safetypharmacovigilancereal-world data

Identifiers

PMID39858904
PMCPMC11767418

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

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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 Socratic graph.