STIVARGA® (regorafenib) safety profile in CORRECT

AEs reported in ≥10% of mCRC patients treated with STIVARGA and reported more commonly than in patients receiving placebo1*

  STIVARGA (n=500) Placebo (n=253)
AEs All grades
(%)
Grade ≥3
(%)
All grades
(%)
Grade ≥3
(%)
General disorders and administration site conditions        
Asthenia/fatigue 64% 15% 46% 9%
Pain 59% 9% 48% 7%
Fever 28% 2% 15% 0%
Metabolism and nutrition disorders        
Decreased appetite and food intake 47% 5% 28% 4%
Skin and subcutaneous tissue disorders        
HFSR/PPES 45% 17% 7% 0%
Rash 26% 6% 4% <1%
Gastrointestinal disorders        
Diarrhea 43% 8% 17% 2%
Mucositis 33% 4% 5% 0%
Investigations        
Weight loss 32% <1% 10% 0%
Infections and infestations        
Infection 31% 9% 17% 6%
Vascular disorders        
Hypertension 30% 8% 8% <1%
Hemorrhage 21% 2% 8% <1%
Respiratory, thoracic, and mediastinal disorders        
Dysphonia 30% 0% 6% 0%
Nervous system disorders        
Headache 10% <1% 7% 0%
  STIVARGA (n=500)
AEs All grades
(%)
Grade ≥3
(%)
General disorders and administration site conditions    
Asthenia/fatigue 64% 15%
Pain 59% 9%
Fever 28% 2%
Metabolism and nutrition disorders    
Decreased appetite and food intake 47% 5%
Skin and subcutaneous tissue disorders    
HFSR/PPES 45% 17%
Rash 26% 6%
Gastrointestinal disorders    
Diarrhea 43% 8%
Mucositis 33% 4%
Investigations    
Weight loss 32% <1%
Infections and infestations    
Infection 31% 9%
Vascular disorders    
Hypertension 30% 8%
Hemorrhage 21% 2%
Respiratory, thoracic, and mediastinal disorders    
Dysphonia 30% 0%
Nervous system disorders    
Headache 10% <1%
  Placebo (n=253)
AEs All grades
(%)
Grade ≥3
(%)
General disorders and administration site conditions    
Asthenia/fatigue 46% 9%
Pain 48% 7%
Fever 15% 0%
Metabolism and nutrition disorders    
Decreased appetite and food intake 28% 4%
Skin and subcutaneous tissue disorders    
HFSR/PPES 7% 0%
Rash 4% <1%
Gastrointestinal disorders    
Diarrhea 17% 2%
Mucositis 5% 0%
Investigations    
Weight loss 10% 0%
Infections and infestations    
Infection 17% 6%
Vascular disorders    
Hypertension 8% <1%
Hemorrhage 8% <1%
Respiratory, thoracic, and mediastinal disorders    
Dysphonia 6% 0%
Nervous system disorders    
Headache 7% 0%

AEs can occur at any time during the course of treatment. Monitoring is critical during the first cycle and throughout therapy2,3

Frequency of select treatment-related AEs ≥Grade 3 occurring in ≥5% of patients in either arm of CORRECT2,4§

HFSR

Adverse events can occur at any time during the course of treatment.

Fatigue

Adverse events can occur at any time during the course of treatment.

Diarrhea

Adverse events can occur at any time during the course of treatment.

Hypertension

Adverse events can occur at any time during the course of treatment.

Rash/Desquamation

Adverse events can occur at any time during the course of treatment.

Toxicity-related discontinuation

  • 8.2% of STIVARGA patients discontinued treatment because of drug-related AEs vs 1.2% of placebo patients1
  • Skin toxicity (HFSR/PPE or rash) was the most common cause of permanent drug discontinuation1