Evidence map›Paper›PMID 29266794›Full record

Trial reportClinical pharmacology in drug development2018

Determination of Seminal Concentration of Fingolimod and Fingolimod-Phosphate in Multiple Sclerosis Patients Receiving Chronic Treatment With Fingolimod.

Olivier J David, Amy Berwick, Nicole Pezous, Michael Lang, Klaus Tiel-Wilck, Tjalf Ziemssen, Peng Li, Hisanori Hara, Robert Schmouder

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical pharmacology in drug development, 2018. 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
–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

2 citing papers in PubMed.

  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

9 authors.

Olivier J DavidNovartis Pharma AG, Basel, Switzerland.
Amy BerwickNovartis Institutes for Biomedical Research, Cambridge, MA, USA.
Nicole PezousNovartis Pharma AG, Basel, Switzerland.
Michael LangNeuroPoint, Ulm and NTD Study Group, Ulm, Germany.
Klaus Tiel-WilckNeurologisches Facharztzentrum, NTD Study Group, Berlin, Germany.
Tjalf ZiemssenTechnische Universität, Dresden, Germany.
Peng LiWuXi AppTec Co, Shanghai, China.
Hisanori HaraNovartis Pharma AG, Basel, Switzerland.
Robert SchmouderNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The safety profile of fingolimod 0.5 mg, approved therapy for relapsing multiple sclerosis, is well established in clinical and real-world studies. As fingolimod is teratogenic in rats, it was considered important to assess the concentrations of fingolimod and its active metabolite, fingolimod-phosphate, in the semen of male patients on treatment and the risk of harming a fetus in a pregnant partner. In this multicenter open-label study, 13 male patients receiving fingolimod for at least 6 months provided 1 semen and 1 blood sample for analyte concentration measurements. The steady-state seminal concentrations of fingolimod and fingolimod-phosphate were close to those simultaneously observed in blood. The amount of fingolimod-related material in 10 mL of ejaculate was estimated to be 47.5 ng. The estimated fingolimod and fingolimod-phosphate blood C

Indexed as

AdultFingolimod HydrochlorideHumansImmunosuppressive AgentsMaleMiddle AgedMultiple SclerosisPhosphatesSemenFingolimod HydrochlorideImmunosuppressive AgentsPhosphatesbloodfingolimodfingolimod-phosphatesemen

Identifiers

PMID29266794
PMCPMC5814852

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.