Evidence map›Paper›PMID 41973364›Full record

ArticleInternational journal of clinical pharmacy2026

Evaluation of consistency in adverse event reporting between trial registry and publications in COVID-19 pharmacological intervention trials.

Mia Strikić, Shelly Melissa Pranić

Abstract read
In one paragraph

Article in International journal of clinical pharmacy, 2026. 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

2 authors.

Mia StrikićDepartment of Mental Health, Teaching Institute for Public Health Split, Vukovarska 46, 21000, Split, Croatia. miastrikic.ms@gmail.com.ORCID http://orcid.org/0000-0002-3905-7069
Shelly Melissa PranićDepartment of Public Health, University of Split School of Medicine, Šoltanska 2A, 21000, Split, Croatia.ORCID http://orcid.org/0000-0001-5524-1723

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionComplete and consistent reporting of adverse events (AE) affects decisions in clinical practice. We conducted a cross-sectional study aiming to assess transparency and completeness of reported adverse events from randomized clinical trials (RCTs) on pharmacological interventions, including biologicals, to treat Coronavirus disease 2019 (COVID-19) registered on ClinicalTrials.gov on or after January 1, 2020, and updated on or before May 31, 2021, along with corresponding publications.

aimWe aimed to assess the completeness and consistency of adverse event and all-cause mortality reporting between ClinicalTrials.gov and corresponding publications.

methodWe conducted a cross-sectional comparison of safety reporting between ClinicalTrials.gov registry and peer-reviewed publications of RCTs investigating COVID-19 pharmacological interventions, including biologicals. Two authors evaluated RCTs to reach κ ≥ 0.80.

resultsA total of 68 trials were assessed for discrepancies in adverse event and all-cause mortality data. Thirty-one (46%) were industry-funded, and 44 (65%) were double-blind randomized clinical trials. Forty-nine (72%) publications had discordant counts of serious adverse events (SAE) descriptions, 35 (51%) had discrepancies in the number of patients affected by SAE, and 11 (16%) omitted all-cause mortality compared to the records in the ClinicalTrials.gov registry.

conclusionDiscrepant reporting of AEs and essential trial data was high in trials on COVID-19 therapeutics.

Indexed as

Adverse Drug Reaction Reporting SystemsCOVID-19 Drug TreatmentDrug-Related Side Effects and Adverse ReactionsRandomized Controlled Trials as TopicRegistriesCOVID-19Cross-Sectional StudiesHumansAdverse eventsClinicalTrials.govCOVID-19Drug safetyRandomized controlled trials

Identifiers

PMID41973364
PMCPMC13369681

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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 OpenQuestion graph.