Evidence map›Paper›PMID 27695289›Full record

ArticleDrug design, development and therapy2016

Gender differences in the adverse events' profile registered in seven observational studies of a wide gender-medicine (MetaGeM) project: the MetaGeM safety analysis.

Delia Colombo, Emanuela Zagni, Mihaela Nica, Sara Rizzoli, Alessandra Ori, Gilberto Bellia

Open access · goldAbstract read
In one paragraph

Article in Drug design, development and therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 16% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

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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 at 1 institution in 1 country.

Delia ColomboPatient Access, Novartis Farma S.p.A., Origgio, Varese.
Emanuela ZagniPatient Access, Novartis Farma S.p.A., Origgio, Varese.
Mihaela NicaPatient Access, Novartis Farma S.p.A., Origgio, Varese.
Sara RizzoliMediNeos Observational Research, Modena, Italy.
Alessandra OriMediNeos Observational Research, Modena, Italy.
Gilberto BelliaPatient Access, Novartis Farma S.p.A., Origgio, Varese.
Novartis (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity.

methodsData were collected between February 2002 and July 2013. Male and female patients were compared for the main safety variables, using Student's

resultsIn total, 4,870 patients (46% females, 54% males) were included in the analysis; age was higher for females (mean ± standard deviation 61.2±18.3 years) than males (56.3±16.6 years). Overall, 264 AEs were reported (59.1% in males). There were no significant gender differences in the percentage of patients with at least one AE: 3.0% for females versus 3.9% for males,

conclusionThis safety analysis on a large sample of almost 5,000 patients with different diseases and treated with a wide range of different drugs provides a useful overview on possible gender differences in drug tolerability, which may be helpful in more accurately designing future clinical trials from a gender-specific perspective.

Indexed as

Gender IdentityFemaleHumansIncidenceMaleadverse eventsdrugsgendermeta-analysissafety

Identifiers

PMID27695289
PMCPMC5028083
OpenAlexW2519542573

What OpenQuestion holds

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LicenceCC BY-NC
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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.