NEXAVAR® (sorafenib) in locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine therapy

Safety in the DECISION study

Selected adverse reactions occurring at a higher incidence in
NEXAVAR-treated patients1*
 NEXAVAR (n=207)Placebo (n=209)
Adverse Reaction NCI-CTCAE v3.0All grades
(%)
Grade 3 or 4
(%)
All grades
(%)
Grade 3 or 4
(%)
Skin and subcutaneous tissue disorders    
PPES691980
Alopecia67080
Rash35570
Pruritus200.5110
Dry skin130.550
Erythema1000.50
Hyperkeratosis7000
Gastrointestinal disorders    
Diarrhea686151
Stomatitis24230
Nausea210120
Abdominal pain§20171
Constipation16080.5
Oral pain140.560
Vomiting11030
Investigations    
Weight loss496141
General disorders and administration site conditions    
Fatigue415201
Asthenia12070
Pyrexia11150
Vascular Disorders    
Hypertension#4110122
Metabolism and nutrition disorders    
Decreased appetite30250
Nervous system disorders    
Headache17060
Dysgeusia6000
Musculoskeletal and connective tissue disorders    
Pain in extremity15170
Muscle spasms10030
Respiratory, thoracic and mediastinal disorders    
Dysphonia130.530
Epistaxis7010
Neoplasms benign, malignant and unspecified    
Squamous cell carcinoma of skin3300
 NEXAVAR (n=207)
Adverse Reaction
NCI-CTCAE v3.0
All grades
 (%)
Grade 3 or 4  
 (%)
Skin and subcutaneous tissue disorders  
PPES6919
Alopecia670
Rash355
Pruritus200.5
Dry skin130.5
Erythema100
Hyperkeratosis70
Gastrointestinal disorders  
Diarrhea686
Stomatitis242
Nausea210
Abdominal pain§201
Constipation160
Oral pain140.5
Vomiting110
Investigations  
Weight loss496
General disorders and administration site conditions  
Fatigue415
Asthenia120
Pyrexia111
Vascular Disorders  
Hypertension#4110
Metabolism and nutrition disorders  
Decreased appetite302
Nervous system disorders  
Headache170
Dysgeusia60
Musculoskeletal and connective tissue disorders  
Pain in extremity151
Muscle spasms100
Respiratory, thoracic and mediastinal disorders  
Dysphonia130.5
Epistaxis70
Neoplasms benign, malignant and unspecified  
Squamous cell carcinoma of skin33
 Placebo (n=209)
Adverse Reaction
NCI- CTCAE v3.0
All grades
 (%)
Grade 3 or 4  
 (%)
Skin and subcutaneous tissue disorders  
PPES80
Alopecia80
Rash70
Pruritus110
Dry skin50
Erythema0.50
Hyperkeratosis00
Gastrointestinal disorders  
Diarrhea151
Stomatitis30
Nausea120
Abdominal pain§71
Constipation80.5
Oral pain60
Vomiting30
Investigations  
Weight loss141
General disorders and administration site conditions  
Fatigue201
Asthenia70
Pyrexia50
Vascular Disorders  
Hypertension#122
Metabolism and nutrition disorders  
Decreased appetite50
Nervous system disorders  
Headache60
Dysgeusia00
Musculoskeletal and connective tissue disorders  
Pain in extremity70
Muscle spasms30
Respiratory, thoracic and mediastinal disorders  
Dysphonia30
Epistaxis10
Neoplasms benign, malignant and unspecified  
Squamous cell carcinoma of skin00
Laboratory test abnormalities reported in DECISION1
 NEXAVAR (n=207)Placebo (n=209)
Laboratory Parameter NCI-CTCAE v3.0All grades
 (%)
Grade 3 or 4
 (%)
All grades
 (%)
Grade 3 or 4
 (%)
Elevated ALT594240
Elevated AST542150
Hypocalcemia3610113
 NEXAVAR (n=207)
Laboratory Parameter
NCI-CTCAE v3.0
All grades
 (%)
Grade 3 or 4
 (%)
Elevated ALT594
Elevated AST542
Hypocalcemia3610
 Placebo (n=209)
Laboratory Parameter
NCI-CTCAE v3.0
All grades
 (%)
Grade 3 or 4
 (%)
Elevated ALT240
Elevated AST150
Hypocalcemia113

DECISION (StuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine-refractory thyrOid caNcer) study: A randomized, double-blind, placebo-controlled, multicenter study in patients with locally recurrent or metastatic, progressive, DTC refractory to RAI (N=417).1

DECISION (StuDy of sorafEnib in loCally advanced or metastatIc patientS with radioactive Iodine-refractory thyrOid caNcer) study: A randomized, double-blind, placebo-controlled, multicenter study in patients with locally recurrent or metastatic, progressive, DTC refractory to RAI (N=417).1

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