Evidence map›Paper›PMID 33282307›Full record

ArticleSAGE open medicine2020

Assessment of Reye's syndrome profile with data from the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases using the disproportionality analysis.

Kiyoka Matsumoto, Shiori Hasegawa, Satoshi Nakao, Kazuyo Shimada, Ririka Mukai, Mizuki Tanaka, Riko Satake, Yu Yoshida, Fumiya Goto, Misaki Inoue and 4 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in SAGE open medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 43% of its field
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

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. 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

14 authors at 2 institutions in 1 country.

Kiyoka MatsumotoLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Shiori HasegawaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Satoshi NakaoLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Kazuyo ShimadaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Ririka MukaiLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Mizuki TanakaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Riko SatakeLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Yu YoshidaLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Fumiya GotoLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Misaki InoueLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.
Hiroaki IkesueDepartment of Pharmacy, Kobe City Medical Center General Hospital, Hyogo, Japan.
Kazuhiro IguchiLaboratory of Community Pharmacy, Gifu Pharmaceutical University, Gifu, Japan.
Tohru HashidaDepartment of Pharmacy, Kobe City Medical Center General Hospital, Hyogo, Japan.
Mitsuhiro NakamuraLaboratory of Drug Informatics, Gifu Pharmaceutical University, Gifu, Japan.ORCID https://orcid.org/0000-0002-5062-5522
Gifu Pharmaceutical University · JPKobe City Medical Center General Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesReye's syndrome is a rare and potentially fatal illness that is defined as encephalopathy accompanied by liver failure. The aim of this study was to assess Reye's syndrome profiles by analyzing data from the spontaneous reporting system database.

methodsWe analyzed reports of Reye's syndrome using the US Food and Drug Administration Adverse Event Reporting System and the Japanese Adverse Drug Event Report databases. The reporting odds ratio and proportional reporting rate were used to detect the pharmacovigilance signal.

resultsThe US Food and Drug Administration Adverse Event Reporting System contains 12,201,620 reports from January 2004 to June 2020, of which 186 are on Reye's syndrome. The Japanese Adverse Drug Event Report contains 646,779 reports from April 2004 to September 2020, of which 30 are on Reye's syndrome. In the US Food and Drug Administration Adverse Event Reporting System database, the reporting odds ratios (95% confidence interval, number of cases) of aspirin, diclofenac, ibuprofen, acetaminophen, and valproate sodium were 404.6 (302.6-541.0, n = 80), 15.1 (6.7-34.1, n = 6), 26.2 (16.1-42.6, n = 18), 10.7 (5.5-20.9, n = 9), and 47.1 (26.2-84.6, n = 12), respectively. In the Japanese Adverse Drug Event Report database, the reporting odds ratios (95% confidence interval, number of cases) of aspirin, diclofenac, ibuprofen, loxoprofen, acetaminophen, and valproate sodium were 14.1 (5.4-36.8, n = 5), 51.7 (22.2-120.5, n = 7), 135.0 (40.8-446.2, n = 3), 17.6 (6.7-46.0, n = 5), 24.0 (9.2-62.6, n = 5), and 13.8 (3.3-57.9, n = 2), respectively. The reported number of female patients aged 30-39 years was the highest in the Japanese Adverse Drug Event Report.

conclusionAlthough the frequency of the occurrence of Reye's syndrome is low, the possible risk of the disease occurring in adult females should be considered.

Indexed as

FDA Adverse Event Reporting System databaseJapanese Adverse Drug Event Report databasePharmacoepidemiology/drug safetyReye’s syndrome

Identifiers

PMID33282307
PMCPMC7686594
OpenAlexW3108956286

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.