Trial reportAdvances in therapy2024
A Randomized, Open-Label Study Conducted to Evaluate the Bioequivalence of Pegfilgrastim-cbqv On-Body Injector Versus Prefilled Syringe in Healthy Male Participants.
Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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.
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.
Who cites it
1 citing paper in PubMed, 2 citations in OpenAlex.
- Mapping supportive-care evidence for febrile neutropenia prevention in breast cancer chemotherapy: a bibliometric analysis of long-acting G-CSF prophylaxis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTo help prevent febrile neutropenia, pegfilgrastim-cbqv (UDENYCA
methodsIn this open-label, two-period crossover study, healthy adult male participants (N = 189) were randomly assigned 1:1 to receive pegfilgrastim-cbqv 6 mg subcutaneously using an OBI (n = 92) or a PFS (n = 95) in period 1 and then an injection via the other method in period 2. Primary PK end points were area under the concentration-time curve from time 0 to infinity, area under the concentration-time curve from time 0 to the last quantifiable concentration, and maximum plasma concentration. Secondary PD end points, safety, immunogenicity, and tolerability were also assessed.
resultsThe 90% confidence intervals (CIs) of the geometric mean ratios for the PK and PD end points fell within the predetermined range (80-125%), indicating PK and PD bioequivalence between pegfilgrastim-cbqv OBI and pegfilgrastim-cbqv PFS. Treatment-emergent adverse events (TEAEs) occurred in 87.8% and 75.8% of participants in the OBI and PFS groups, respectively. Most TEAEs were musculoskeletal effects. The most common OBI-related TEAE was injection site erythema (31.7%), which was mild, transient, and self-limiting. The incidence of treatment-emergent antidrug antibodies (ADAs) was similar between the OBI and PFS. ADAs had no apparent impact on PK, PD, or safety. Neutralizing antibodies were not detected in any participant.
conclusionsResults of the study showed PK and PD bioequivalence of pegfilgrastim-cbqv administered using OBI compared with PFS. OBI and PFS administration had similar safety, tolerability, and immunogenicity profiles. No unexpected safety signals were identified. Graphical Abstract available for this article.
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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.