ArticleDrug safety2026
Ponatinib Safety Profile: An Analysis of 10 Years of Real-World Experience.
Article in Drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled 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.
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, 1 synthesis or guideline pooled it.
- [Guideline for the diagnosis and treatment of chronic myeloid leukemia in China (2025)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Guideline
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPonatinib is a third-generation BCR::ABL1 tyrosine kinase inhibitor indicated for the treatment of chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia. Following its initial commercial availability in the USA on 14 December 2012, safety concerns, notably vascular occlusive events, led to the implementation of post-approval risk-management measures (RMMs).
objectiveThis retrospective study assessed the impact of these measures on adverse event (AE) reporting rates for ponatinib's important identified risks (IIRs).
methodsAEs related to ponatinib's IIRs were identified from the Incyte Global Safety Database for the period 14 December 2012 to 13 December 2022, using a Medical Dictionary for Regulatory Activities-based search of postmarketing reports. Reporting rates were calculated as the ratio of reported AEs to estimated postmarketing exposure.
resultsDuring the first year of commercialization, the most frequently reported AEs for ponatinib pertained to the IIRs of myelosuppression, skin reactions, infections, and arterial occlusive events, with reporting rates of 0.505, 0.362, 0.330, and 0.291, respectively. Following implementation of post-approval RMMs in December 2013, reporting rates of these IIRs decreased considerably during the first 2 years of commercialization. By the end of year 10, reporting rates of these IIRs further decreased to 0.043, 0.030, 0.045, and 0.038, respectively. Notably, reporting rates for each IIR across the 10-year period were considerably lower than the reporting rates observed during the first year of ponatinib commercialization.
conclusionThis study shows declining AE reporting rates for ponatinib's IIRs since it first became commercially available, potentially because of the implementation of RMMs and increased clinicians' awareness.
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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.