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.