Trial reportJournal of the National Cancer Institute2021
Inferences About Drug Safety in Phase III Trials in Oncology: Examples From Advanced Prostate Cancer.
Trial report in Journal of the National Cancer Institute, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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
11 citing papers in PubMed, 19 citations in OpenAlex.
- Review
- Under the radar-frequency, timing, duration, and trajectory of lower-grade adverse events in clinical trials of anti-cancer therapies.The oncologist · 2025Article
- Adverse events of androgen receptor pathway inhibitors in prostate cancer from real world data.PloS one · 2025Article
- MYO6 contributes to tumor progression and enzalutamide resistance in castration-resistant prostate cancer by activating the focal adhesion signaling pathway.Cell communication and signaling : CCS · 2024Article
- A real-world disproportionality analysis of apalutamide: data mining of the FDA adverse event reporting system.Frontiers in pharmacology · 2023Article
- Functional impact of androgen-targeted therapy on patients with castration-resistant prostate cancer.BJUI compass · 2022Review
- Article
- Apalutamide, Darolutamide and Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer (nmCRPC): A Critical Review.Cancers · 2022Review
- Anxiety and Coping Stress Strategies in Researchers During COVID-19 Pandemic.Frontiers in public health · 2022Article
- Unlocking the potential of antibody-drug conjugates for cancer therapy.Nature reviews. Clinical oncology · 2021Review
- Advancing Assessment, Analysis, and Reporting of Safety and Tolerability in Cancer Trials.Journal of the National Cancer Institute · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundSafety is a central consideration when choosing between multiple medications with similar efficacy. We aimed to evaluate whether adverse event (AE) profiles of 3 such drugs in advanced prostate cancer could be distinguished based on published literature.
methodsWe assessed consistency in AE reporting, AE risk in placebo arms, and methodology used for risk estimates and quantification of statistical uncertainty in randomized placebo-controlled phase III trials of apalutamide, enzalutamide, and darolutamide in advanced prostate cancer.
resultsSeven included clinical trials enrolled a total of 9215 participants (range = 1051-1715 per trial) across 3 prostate cancer disease states. Within disease states, baseline patient characteristics appeared similar between trials. Of 54 distinct AE types in total, only 3 (fatigue, hypertension, and seizure) were reported by all 7 trials. Absolute risks of AEs in the placebo arms differed systematically and more than twofold between trials, which was associated with visit frequency and resulted in different degrees of uncertainty in AE profiles between trials. No trial used inferential methodology to quantify statistical uncertainty in AE risks, but 6 of 7 trials drew overall conclusions. Two trials concluded that there was no elevated AE risk because of the intervention, including the trial of darolutamide, which had the greatest statistical uncertainty.
conclusionsRigorous comparison of drug safety was precluded by heterogeneity in AE reporting, variation in AE risks in the placebo arms, and lack of inferential statistical methodology, underscoring considerable opportunities to improve how AE data are collected, analyzed, and interpreted in oncology trials.
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