ArticleInternational journal of medical sciences2012
Adverse event profiles of 5-fluorouracil and capecitabine: data mining of the public version of the FDA Adverse Event Reporting System, AERS, and reproducibility of clinical observations.
Article in International journal of medical sciences, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07346677 (Comparing of Sesame Oil, Nitroglycerin Ointment, and Aloe Vera Gel on Prevention of Phlebitis Induced by Chemotherapy), which is not on this map. Cited by 34 papers, 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.
Comparing of Sesame Oil, Nitroglycerin Ointment, and Aloe Vera Gel on Prevention of Phlebitis Induced by Chemotherapy
Who cites it
34 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.
- Traditional Chinese medicines and capecitabine-based chemotherapy for colorectal cancer treatment: A meta-analysis.Cancer medicine · 2023Pooled it
- Montelukast attenuates intestinal mucositis induced by 5-fluorouracil via upregulation of HO-1 and PPAR-γ and suppression of TLR4/NF-κB/HMGB1 and caspase-3 pathways.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Article
- The impact of diet-induced obesity on 5 fluorouracil-induced tumor and liver immune cell cytotoxicity.American journal of physiology. Cell physiology · 2025Article
- Stimuli-Responsive Liposomes of 5-Fluorouracil: Progressive Steps for Safe and Effective Treatment of Colorectal Cancer.Pharmaceutics · 2024Review
- Capecitabine-induced severe adverse events-therapeutic drug monitoring andBMJ case reports · 2024Article
- Molecular Actions ofAnti-cancer agents in medicinal chemistry · 2024Article
- A peptide derived from interleukin-10 exhibits potential anticancer activity and can facilitate cell targeting of gold nanoparticles loaded with anticancer therapeutics.Communications chemistry · 2023Article
- Polysaccharides from Passion Fruit Peels: From an Agroindustrial By-Product to a Viable Option for 5-FU-Induced Intestinal Damage.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Advanced statistics identification of participant and treatment predictors associated with severe adverse effects induced by fluoropyrimidine-based chemotherapy.Cancer chemotherapy and pharmacology · 2023Article
- Recent advances in electrochemical determination of anticancer drug 5-fluorouracil.ADMET & DMPK · 2023Review
- Characterization of ADME Gene Variation in Colombian Population by Exome Sequencing.Frontiers in pharmacology · 2022Article
- Preclinical Toxicity and Safety of MM-129-First-in-Class BTK/PD-L1 Inhibitor as a Potential Candidate against Colon Cancer.Pharmaceutics · 2021Article
- Drug-related problems and risk factors related to unplanned hospital readmission among cancer patients in Belgium.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021Article
- In Situ Delivery and Production System (Journal of personalized medicine · 2021Review
- Oral drugs in the treatment of metastatic colorectal cancer.Therapeutic advances in medical oncology · 2021Review
- Eltrombopag to allow chemotherapy in a patient with MYH9-related inherited thrombocytopenia and pancreatic cancer.International journal of hematology · 2020Article
- Pharmacogenetic Variants in theArchives of pharmacology and therapeutics · 2020Article
- Metastatic colorectal cancer and severe hypocalcemia following irinotecan administration in a patient with X-linked agammaglobulinemia: a case report.BMC medical genetics · 2019Article
- Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe safety profiles of oral fluoropyrimidines were compared with 5-fluorouracil (5-FU) using adverse event reports (AERs) submitted to the Adverse Event Reporting System, AERS, of the US Food and Drug Administration (FDA).
methodsAfter a revision of arbitrary drug names and the deletion of duplicated submissions, AERs involving 5-FU and oral fluoropyrimidines were analyzed. Standardized official pharmacovigilance tools were used for the quantitative detection of signals, i.e., drug-associated adverse events, including the proportional reporting ratio, the reporting odds ratio, the information component given by a Bayesian confidence propagation neural network, and the empirical Bayes geometric mean.
resultsBased on 22,017,956 co-occurrences, i.e., drug-adverse event pairs, found in 1,644,220 AERs from 2004 to 2009, it was suggested that leukopenia, neutropenia, and thrombocytopenia were more frequently accompanied by the use of 5-FU than capecitabine, whereas diarrhea, nausea, vomiting, and hand-foot syndrome were more frequently associated with capecitabine. The total number of co-occurrences was not large enough to compare tegafur, tegafur-uracil (UFT), tegafur-gimeracil-oteracil potassium (S-1), or doxifluridine to 5-FU.
conclusionThe results obtained herein were consistent with clinical observations, suggesting the usefulness of the FDA's AERS database and data mining methods used, but the number of co-occurrences is an important factor in signal detection.
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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.