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Adverse Event reporting can be found at the bottom of the page | Prescribing Information for the relevant medicine can be found adjacent to the below content and/or in the footer below.

Managing adverse events
Nexavar® (sorafenib) offers an established generally manageable AE profile
In the pivotal SHARP trial:*
- AEs with Nexavar were typically mild to moderate in severity
- Diarrhoea, weight loss, HFSR, alopecia, anorexia and voice changes were more frequent with Nexavar (p<0.001)
- Grade 3 drug-related adverse events included diarrhoea, HFSR, hypertension and abdominal pain, of which diarrhoea and HFSR were most relevant (each affecting 8% of Nexavar patients vs. 2% and 1% of placebo patients, respectively [p<0.001])

For the full list of AEs, please refer to the Summary of Product Characteristics.
* SHARP was a randomised, double-blind, placebo-controlled, international, multicentre, Phase III study in patients with unresectable HCC (n=602). The safety population included 297 patients in the Nexavar group and 302 patients in the placebo group.
Stivarga® (regorafenib) offers an established and generally manageable AE profile
In the RESORCE trial:*
- AEs were reported in all Stivarga patients and 93% of placebo patients (these were deemed possibly study-drug related in 93% and 52% of patients, respectively)
- The most common clinically relevant grade 3 or 4 treatment-emergent events were hypertension, HFSR, fatigue, diarrhoea and constipation

For the full list of AEs, please refer to the Summary of Product Characteristics.
* RESORCE: a Phase III study of Stivarga vs. placebo in patients with unresectable HCC who had progressed during Nexavar treatment (n=573). The safety population included 374 patients in the Stivarga group and 193 patients in the placebo group.
PP-NEX-GB-0226 | March 2025
- Referencesexpand_more
- 1Lencioni R et al. Int J Clin Pract 2014;68(5):609-617.
- 2Bruix J et al. Lancet 2017;389(10064):56-66.
- 3Finn RS et al. J Hepatol 2018;69(2):353-358.
- 4Llovet JM et al. N Engl J Med 2008;359(4):378-390.
- 5Grothey A et al. Oncologist 2014;19(6):669-680.
- 6Nexavar (sorafenib) Summary of Product Characteristics.
- 7Stivarga (regorafenib) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/1263/smpc (Last Accessed February 2024)
- 8Bruix J et al. Updated Overall Survival (OS) analysis from the international, Phase III, randomized placebo-controlled RESORCE trial of regorafenib for patients with hepatocellular carcinoma (HCC) who progressed on sorafenib treatment. Abstract no. O-009. ESMO Congress, Barcelona, 2017.