Evidence map›Paper›PMID 36861188›Full record

ArticleCPT: pharmacometrics & systems pharmacology2023

Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder.

Samira J Merali, Wonkyung Byon, Yogesh T Patel, Amira Elsrougy, David Marchisin, Vidya Perera, Weidong Chen, Bing He, Bindu Murthy

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01707394 (Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–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.

NCT01707394 phase1completednot on this map

Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder

TypeinterventionalSponsorBristol-Myers SquibbRan2013 to 2020Enrolled49ConditionsThromboembolismArmsApixaban
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. 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.

Samira J MeraliBristol Myers Squibb, Princeton, New Jersey, USA.ORCID 0000-0001-6659-3687
Wonkyung ByonPfizer, New York, New York, USA.
Yogesh T PatelCognigen Corp, Buffalo, New York, USA.
Amira ElsrougyBristol Myers Squibb, Princeton, New Jersey, USA.
David MarchisinBristol Myers Squibb, Princeton, New Jersey, USA.
Vidya PereraBristol Myers Squibb, Princeton, New Jersey, USA.
Weidong ChenBristol Myers Squibb, Princeton, New Jersey, USA.
Bing HeBristol Myers Squibb, Princeton, New Jersey, USA.
Bindu MurthyBristol Myers Squibb, Princeton, New Jersey, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Apixaban is an oral small-molecule, direct factor Xa (FXa) inhibitor approved in adults for treatment of deep vein thrombosis and pulmonary embolism, and for reducing risk of venous thromboembolism recurrence after initial anticoagulant therapy. This phase I study (NCT01707394) evaluated the pharmacokinetics (PKs), pharmacodynamics (PDs), and safety of apixaban in pediatric subjects (<18 years), enrolled by age group, at risk of venous or arterial thrombotic disorder. A single apixaban dose, targeting adult steady-state exposure with apixaban 2.5 mg, was administered using two pediatric formulations: 0.1 mg sprinkle capsule (age <28 days); 0.4 mg/ml solution (age 28 days to <18 years; dose range, 1.08-2.19 mg/m

Indexed as

Factor Xa InhibitorsPyridonesAdolescentAdultAnticoagulantsChildHumansPyrazolesAnticoagulantsapixabanFactor Xa InhibitorsPyrazolesPyridones

Identifiers

PMID36861188
PMCPMC10088081

What OpenQuestion holds

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Registered trials

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.