Regular monitoring is critical for management of adverse events (AEs)1

  • Patients taking STIVARGA® (regorafenib) should be managed with weekly monitoring and proactive intervention, especially during the first 2 weeks of treatment

Adverse drug reactions (≥10%) reported in patients treated with STIVARGA in GRID and reported more commonly than in patients receiving placebo*

Drug-related AEs occurring in ≥10% of patients in the GRID trial2*

 STIVARGA (n=132)Placebo (n=66)
Adverse reactionsAll grades
%
Grades ≥3
%
All grades
%
Grades ≥3
%
Skin and subcutaneous tissue disorders    
HFSR/PPE6722122
Rash30730
Alopecia24220
General disorders and administration site conditions    
Asthenia/fatigue524392
Fever210112
Vascular disorders    
Hypertension5928275
Hemorrhage11430
Gastrointestinal disorders    
Pain6085514
Diarrhea47890
Mucositis40282
Nausea202122
Vomiting17<180
Respiratory, thoracic, and mediastinal disorders    
Dysphonia39090
Infections and infestations    
Infection32550
Metabolism and nutrition
disorders
    
Decreased appetite and food intake31<1213
Hypothyroidism§18060
Nervous system disorders    
Headache16090
Investigations    
Weight loss14080
Musculoskeletal and
connective tissue disorders
    
Muscle spasms14030
 STIVARGA (n=132)
Adverse reactionsAll grades
%
Grades ≥3
%
Skin and subcutaneous tissue disorders  
HFSR/PPE6722
Rash307
Alopecia242
General disorders and administration site conditions  
Asthenia/fatigue524
Fever210
Vascular disorders  
Hypertension5928
Hemorrhage114
Gastrointestinal disorders  
Pain608
Diarrhea478
Mucositis402
Nausea202
Vomiting17<1
Respiratory, thoracic, and mediastinal disorders  
Dysphonia390
Infections and infestations  
Infection325
Metabolism and nutrition
disorders
  
Decreased appetite and food intake31<1
Hypothyroidism§180
Nervous system disorders  
Headache160
Investigations  
Weight loss140
Musculoskeletal and
connective tissue disorders
  
Muscle spasms140
 Placebo (n=66)
Adverse reactionsAll grades
%
Grades ≥3
%
Skin and subcutaneous tissue disorders  
HFSR/PPE122
Rash30
Alopecia20
General disorders and administration site conditions  
Asthenia/fatigue392
Fever112
Vascular disorders  
Hypertension275
Hemorrhage30
Gastrointestinal disorders  
Pain5514
Diarrhea90
Mucositis82
Nausea122
Vomiting80
Respiratory, thoracic, and mediastinal disorders  
Dysphonia90
Infections and infestations  
Infection50
Metabolism and nutrition
disorders
  
Decreased appetite and food intake213
Hypothyroidism§60
Nervous system disorders  
Headache90
Investigations  
Weight loss80
Musculoskeletal and
connective tissue disorders
  
Muscle spasms30
  • Adverse reactions that resulted in treatment discontinuation were reported in 2.3% of STIVARGA-treated patients compared to 1.5% of patients who received placebo

Some AEs may occur early in the course of treatment, so it′s important to evaluate patients early and often