Evidence map›Paper›PMID 29727013›Full record

Trial reportEpilepsia2018

Everolimus dosing recommendations for tuberous sclerosis complex-associated refractory seizures.

David N Franz, John A Lawson, Zuhal Yapici, Christian Brandt, Michael H Kohrman, Michael Wong, Mathieu Milh, Adelheid Wiemer-Kruel, Maurizio Voi, Neva Coello and 3 more

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Epilepsia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
4.0field-weighted citation impact, top 6% 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

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Phase I/II Trial of Exemestane, Ribociclib, and Everolimus in Women with HRClinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Neurofibromatosis type1, type 2, tuberous sclerosis and Von Hippel-Lindau disease.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2023
    Article
  10. Seizure reduction in TSC2-mutant mouse model by an mTOR catalytic inhibitor.Annals of clinical and translational neurology · 2023
    Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Review
  20. Precision dosing to avoid adverse drug reactions.Therapeutic advances in drug safety · 2019
    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

13 authors at 11 institutions in 6 countries.

David N FranzDepartment of Neurology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
John A LawsonTuberous Sclerosis Multidisciplinary Management Clinic, Sydney Children's Hospital, Randwick, New South Wales, Australia.
Zuhal YapiciDivision of Child Neurology, Department of Neurology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.
Christian BrandtBethel Epilepsy Center, Mara Hospital, Bielefeld, Germany.ORCID 0000-0001-8666-1640
Michael H KohrmanNeuroDevelopmental Science Center, University of Chicago, Chicago, IL, USA.
Michael WongDepartment of Neurology, Washington University School of Medicine, St. Louis, MO, USA.
Mathieu MilhPediatric Neurology Service, Aix-Marseille University, Marseille, France.
Adelheid Wiemer-KruelEpilepsy Center Kork/TSC Center, Kehl-Kork, Germany.
Maurizio VoiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Neva CoelloNovartis Pharmaceuticals AG, Basel, Switzerland.
Wing CheungNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Kai GroschNovartis Pharmaceuticals AG, Basel, Switzerland.
Jacqueline A FrenchNew York University Comprehensive Epilepsy Center, New York, NY, USA.
Novartis (Switzerland) · CHNovartis (United States) · USAix-Marseille Université · FRCincinnati Children's Hospital Medical Center · USDiakonie Kork · DEEvangelisches Krankenhaus Bielefeld · DEIstanbul University · TRNew York University · USSydney Children's Hospital · AUUniversity of Chicago · USWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe present analysis examined the exposure-response relationship by means of the predose everolimus concentration (C

methodsA model-based approach was used to predict patients' daily C

resultsThere was a strong, consistent, and highly significant relationship between everolimus exposure and efficacy, measured by TN-C SIGNIFICANCE: The recommended TDM is to target everolimus C

Indexed as

AdolescentAdultAge FactorsChildChild, PreschoolCytochrome P-450 CYP3A InducersDose-Response Relationship, DrugDouble-Blind MethodDrug MonitoringEverolimusFemaleHumansImmunosuppressive AgentsMaleMiddle AgedSeizuresCytochrome P-450 CYP3A InducersEverolimusImmunosuppressive AgentsdoserefractoryseizuresTDMTSC

Identifiers

PMID29727013
PMCPMC6033043
OpenAlexW2801624490

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.