Observational studyBMC medical research methodology2022
Reporting of the safety from allergic rhinitis trials registered on ClinicalTrials.gov and in publications: An observational study.
Observational study in BMC medical research methodology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled 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.
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.
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Cosmetic Botulinum Toxin A Injections to the Upper Face: A Systematic Review and Meta-Analysis of Clinical Studies.Journal of cosmetic dermatology · 2026Pooled it
- Systematic review with cross sectional comparative analysis identifies adverse event reporting discrepancies between ClinicalTrials.gov and published glaucoma randomized controlled trials.Scientific reports · 2025Pooled it
- Time to publication for results of clinical trials.The Cochrane database of systematic reviews · 2024Pooled it
- Article
- Evaluation of consistency in adverse event reporting between trial registry and publications in COVID-19 pharmacological intervention trials.International journal of clinical pharmacy · 2026Article
- Assessing the Completeness of Adverse Event Reporting in Clinical Trials of Psoriasis Treatments: A Registry-Publication Comparison Study.Clinical drug investigation · 2026Article
- Consistency Between Clinical Trial Registry Entries and Journal Publications in Transfusion Medicine: An Observational Study.Journal of clinical medicine · 2026Article
- Clinical research on homeopathic preparations: protocol template for a series of systematic reviews.Systematic reviews · 2026Article
- Completeness and changes in data reporting pharmacological interventions to treat COVID-19.Scientific reports · 2025Article
- Discrepancies in safety reporting for chronic back pain clinical trials: an observational study from ClinicalTrials.gov and publications.BMC medical research methodology · 2025Observational
- Safety reporting in trials on glaucoma interventions registered in ClinicalTrials.gov and corresponding publications.Scientific reports · 2024Article
- Reporting characteristics of nonsurgical periodontal therapy trials registered in ClinicalTrials.gov: an observational study.Journal of comparative effectiveness research · 2023Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIncomplete and inconsistent reporting of adverse events (AEs) through multiple sources can distort impressions of the overall safety of the medical interventions examined as well as the benefit-risk relationship. We aimed to assess completed allergic rhinitis (AR) trials registered in ClinicalTrials.gov for completeness and consistency of AEs reporting comparing ClinicalTrials.gov and corresponding publications.
methodsWe retrospectively examined completed randomised controlled trials on AR registered in ClinicalTrials.gov on or after 9/27/2009 to trials updated with results on or before 12/31/2021 along with any corresponding publications. Complete reporting of AEs in ClinicalTrials.gov were summarised in tables describing AE information, and complete reporting in publications was an explicit statement of serious AE, death or other AE. Difference in completeness, number, or description of AEs between ClinicalTrials.gov and publication was classified as inconsistent reporting of AEs.
resultsThere were 99 registered trials with 45 (45.5%) available publications. All published trials completely reported AEs in ClinicalTrials.gov, and 21 (46.7%) in publications (P < .001). In 43 (95.6%) publications, there was at least one inconsistency in the reporting of AEs (P < .001). 8 (17.8%) publications had different number of serious AEs (P = .003), 36 (80.0%) of other AEs (P < .001) while deaths reporting was inconsistent in 8 (57.1%) publications (P = .127).
conclusionThe reporting of AEs from AR trials is complete in ClinicalTrials.gov and incomplete and inconsistent in corresponding publications. There is a need to improve the reporting of AEs from AR trials in corresponding publications, and thus to improve patient safety.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.