It’s time to stop calling adverse events ‘manageable’

There is a phrase embedded across oncology trial publications, patient information leaflets, and plain language summaries. It is used to reassure and simplify complex experiences.

‘Manageable toxicity’

It sounds reasonable. But for someone living with persistent diarrhoea, fatigue that affects their ability to work, or ongoing peripheral neuropathy, it often describes very little of what they actually experience.

Why language is never neutral

‘Manageable’ is a subjective label. It reflects a judgement, not a description.

It can mean very different things depending on clinical support, dose adjustments, and a patient’s individual circumstances. When that complexity is reduced to a single reassuring word (especially at the point of consent or treatment initiation), the real burden of side effects can be unintentionally underestimated, leaving patients unprepared for the cumulative impact over time.

This matters because we already know that adverse events are not always fully captured in trials, particularly when relying on clinician assessment alone. And people enrolled in trials are often fitter than those seen in everyday clinical practice, meaning a ‘manageable’ profile in a trial may look very different in the real world.¹

Closing the gap between reported and lived experience

Studies have shown that clinicians can systematically under-report the severity of side effects compared with patients themselves.² This disconnect becomes clear in treatments like EGFR-targeted therapies. Although often described as ‘well tolerated’, side effects such as rash, diarrhoea, and fatigue may be labelled as lower grade while still significantly affecting quality of life.³

Incorporating patient perspective helps close this gap. Tools such as the NCI’s PRO-CTCAE are designed to capture a more accurate and complete picture of treatment experience.^2,4 Approaches such as longitudinal toxicity over time analysis can help bring the longer-term picture into focus, too.⁵

Rethinking what ‘manageable’ means

Two recent opinion pieces in Nature Medicine have challenged the continued use of this language.^3,6 Their central argument is simple: manageability depends on the individual patient’s circumstances and the support they have access to.

Evidence supports this re-focus. A 2025 analysis of 407 phase III trials found that only around a third met the standard for complete toxicity reporting and identified terms like ‘manageable’ as part of a wider pattern of language that can unintentionally minimise the burden of side effects.⁷ When adverse events are framed in this way, the picture clinicians rely on becomes less clear and patients may not be fully prepared for what treatment involves.³

What needs to change

The challenge isn’t a lack of rigour. It’s a lack of clarity. Replacing vague labels with specific information can make a meaningful difference in building confidence. Patients need to know:

• How often side effects occur
• How severe they may be
• How long they are likely to last
• What they may experience day to day
• How side effects can be managed in practice

Why this matters to trial outcomes

This is not just a language issue. It has practical implications for sponsors. When adverse events are described in vague or overly reassuring terms, participants may start treatment with expectations that do not match what they later experience. That can weaken informed consent, reduce trust, and make recruitment and retention more difficult over time.⁸

Clearer communication matters because participant experience is closely tied to study completion. When patients feel informed, supported, and better prepared for what treatment may involve, confidence is easier to build and maintain. When the opposite happens, dissatisfaction and disengagement are more likely.^9,10

The pressure to improve is also increasing. Patients now access more health and trial information through online channels, and expectations for transparency are rising. At the same time, the wider regulatory and industry direction is toward more patient-centred communication and greater use of patient-reported evidence.¹¹ Sponsors who continue to rely on vague descriptors risk falling behind both patient expectations and evolving standards.

Still calling side effects ‘manageable’?

It might be time to take a closer look.

At Cuttsy+Cuttsy, we help sponsors and clinical teams turn complex safety data into clear, patient-centred communication. We use language rooted in real experiences, so side effect information is easier to understand and relate to.

The result? Better-informed choices and more confident trial participation.

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Abbreviations

EGFR = Epidermal Growth Factor Receptor; NCI = National Cancer Institute; PRO-CTCAE = Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events.

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References

1. Seruga B, et al. Lancet Oncol. 2016;17(5):e209–e219. Available here.
2. Di Maio M, et al. J Clin Oncol. 2015;33(8):910–915. Available here.
3. Book L. Nat Med. 2026. doi:10.1038/s41591-026-04464-w. Available here.
4. Basch E, et al. J Natl Cancer Inst. 2014;106(9):dju244. Available here.
5. Thanarajasingam G, et al. Lancet Oncol. 2016;17(5):663–670. Available here.
6. Gyawali B. Nat Med. 2026. doi.org/10.1038/s41591-026-04463-x. Available here.
7. Miller AM, et al. JCO Oncol Pract. 2025;21(7):979–988. Available here.
8. Harris AR, Gilbert F. Graefes Arch Clin Exp Ophthalmol. 2022;260(8):2775–2776. Available here.
9. mdgroup (2025). Available here. Accessed: June 2026.
10. Cuttsy+Cuttsy (2026). Available here. Accessed: June 2026.
11. US Food and Drug Administration (2026). Available here. Accessed: June 2026.

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