Evidence map›Paper›PMID 34455570›Full record

ArticleDrugs - real world outcomes2022

Safety and Effectiveness of Plerixafor for Peripheral Blood Stem Cell Mobilization in Autologous Stem Cell Transplantation: Results of a Post-Marketing Surveillance Study.

Nobuhiro Tsukada, Momoko Nishikori, Hiroaki Goto, Rie Kanamori, Satoshi Nishina, Takashi Seto, Shinsuke Iida

Open access · goldAbstract read
In one paragraph

Article in Drugs - real world outcomes, 2022. 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
0.9field-weighted citation impact, top 26% 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

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Review
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

7 authors at 5 institutions in 1 country.

Nobuhiro TsukadaDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Momoko NishikoriDepartment of Hematology/Oncology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Hiroaki GotoDivision of Hematology/Oncology, Kanagawa Children's Medical Center, Kanagawa, Japan.
Rie KanamoriSanofi Genzyme Medical, Oncology Medical, Sanofi K.K., Tokyo, Japan.
Satoshi NishinaMedical Affairs, Post-Authorization Regulatory Studies, Sanofi K.K., Tokyo, Japan.
Takashi SetoMedical Affairs, Post-Authorization Regulatory Studies, Sanofi K.K., Tokyo, Japan.
Shinsuke IidaDepartment of Hematology and Oncology, Nagoya City University Institute of Medical and Pharmaceutical Sciences, Nagoya, Japan. iida@med.nagoya-cu.ac.jp.ORCID http://orcid.org/0000-0002-4951-960X
Sanofi (Japan) · JPJapanese Red Cross Medical Center · JPKanagawa Children's Medical Center · JPKyoto University · JPNagoya City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPlerixafor was approved in Japan in 2016 for peripheral blood stem cell (PBSC) mobilization in autologous stem cell transplantation (A-SCT).

objectiveOur objective was to evaluate the safety and effectiveness of plerixafor in Japanese patients undergoing A-SCT for various indications in real-world practice. PATIENTS AND

methodsThis post-marketing surveillance study included Japanese patients initiating PBSC mobilization with plerixafor for A-SCT. Safety assessments included the incidence of adverse events (AEs) including serious AEs, adverse drug reactions (ADRs), and laboratory variables. Effectiveness assessments were the proportion of patients with the target CD34+ cell yield (≥2 × 10

resultsIn total, 785 patients were registered, and the safety and effectiveness analysis sets comprised 764 and 717 patients, respectively. ADRs occurred in 12.2% of patients, with gastrointestinal disorders (5.5%), laboratory investigations (4.5%), and blood and lymphatic system disorders (3.0%) being the most common. A total of 71.1% of patients had the target CD34+ cell yield within ≤4 days of treatment, with a mean (standard deviation) of 1.3 (0.7) days to reach the target CD34+ cell yield. Over 80% of patients with a baseline CD34+ cell count >2 cells/μL had a target CD34+ cell yield within ≤4 days of treatment.

conclusionsThis large post-marketing surveillance study provided real-world evidence detailing the safety and effectiveness of plerixafor for PBSC mobilization in Japanese patients undergoing A-SCT. Importantly, no new safety concerns were identified, and the safety profile of plerixafor was consistent with the established profile of this drug.

Identifiers

PMID34455570
PMCPMC8844333
OpenAlexW3197131993

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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.