Evidence map›Paper›PMID 28686057›Full record

ArticleJournal of comparative effectiveness research2017

Patient-relevant outcomes associated with generic tamsulosin, levothyroxine and amphetamine in the FDA Adverse Event Reporting System: a pilot study.

Sathiya Priya Marimuthu, Geetha Iyer, Jodi B Segal, Sonal Singh

Abstract read
In one paragraph

Article in Journal of comparative effectiveness research, 2017. 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. Impact and implications of national centralized drug procurement in China.International journal of clinical pharmacy · 2024
    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

4 authors.

Sathiya Priya MarimuthuCenter for Drug Safety & Effectiveness, Johns Hopkins Bloomberg School of Public Health, MD 21205, USA.
Geetha IyerDoctoral Student in Population Health Sciences, Harvard University, Boston, MA 02115, USA.
Jodi B SegalCenter for Drug Safety & Effectiveness, Johns Hopkins Bloomberg School of Public Health, MD 21205, USA.
Sonal SinghDepartment of Medicine, University of Massachusetts Medical School, Worcester, MA 01655, USA.

Funding

Clinical Pharmacology Training ProgramT32GM066691 · NIGMS · JOHNS HOPKINS UNIVERSITY · PI Matthew Michael Ippolito · 2003 to 2026
$6.4M
FDA HHS U01 FD005267NIGMS NIH HHS T32 GM066691
6 · The paper itself

Abstract

aimPatient-reported outcomes associated with adverse events (AEs) reported with generics have not been evaluated. To map AEs associated with generics to the NIH Patient-reported Outcomes Measurement Information System.

methodsWe mapped 381 AEs from 148 case reports of generic tamsulosin, levothyroxine and amphetamine/dextroamphetamine to the physical, mental and social domain of the NIH Patient-Reported Outcomes Measurement Information System after reviewing 1237 case reports in the US FDA's Adverse Event Reporting System (FAERS; 2011-2013).

results75%, 76% and 71% reports were classified under the physical domain for tamsulosin, levothyroxine and amphetamine/dextroamphetamine, while 9%, 9% and 18% reports were classified under the mental domain, respectively.

conclusionFAERS reveals several domains of patient-relevant concerns associated with generic drugs.

Indexed as

AdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overAmphetamineDrugs, GenericFemaleHumansMaleMedical RecordsMiddle AgedPilot ProjectsProspective StudiesTamsulosinThyroxineTreatment OutcomeAmphetamineDrugs, GenericTamsulosinThyroxineamphetamineFAERS databaselevothyroxinepatient-relevant outcomesPROMIS outcometamsulosin

Identifiers

PMID28686057
PMCPMC8819589

What OpenQuestion holds

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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.