Safety in the TARGET Study

Adverse reactions reported in ≥10% of patients and at a higher rate in NEXAVAR® (sorafenib) arm than the placebo arm1
 NEXAVAR (n=451)Placebo (n=451)
Adverse Reaction
NCI-CTCAE v3.0
All grades (%)Grade 3 (%)Grade 4 (%)All grades (%)Grade 3 (%)Grade 4 (%)
Any adverse reaction9531786226
Gastrointestinal symptoms      
Diarrhea432013<10
Nausea23<1019<10
Anorexia16<101310
Vomiting16<101210
Constipation15<1011<10
Dermatology/skin      
Rash/desquamation40<1016<10
Hand-foot skin reaction3060700
Alopecia27<10300
Pruritus19<10600
Dry skin1100400
Constitutional symptoms      
Fatigue375<1283<1
Weight loss10<10600
Cardiovascular, general      
Hypertension173<12<10
Hemorrhage/bleeding      
Hemorrhageall sites152081<1
Pulmonary      
Dyspnea143<1122<1
Neurology      
Neuropathy—sensory13<106<10
Pain      
Pain, abdomen1120920
Pain, headache10<106<10
Pain, joint10206<10
 NEXAVAR (n=451)
Adverse Reaction
NCI-CTCAE v3.0
All grades (%)Grade 3 (%)Grade 4 (%)
Any adverse reaction95317
Gastrointestinal symptoms   
Diarrhea4320
Nausea23<10
Anorexia16<10
Vomiting16<10
Constipation15<10
Dermatology/skin   
Rash/desquamation40<10
Hand-foot skin reaction3060
Alopecia27<10
Pruritus19<10
Dry skin1100
Constitutional symptoms   
Fatigue375<1
Weight loss10<10
Cardiovascular, general   
Hypertension173<1
Hemorrhage/bleeding   
Hemorrhageall sites1520
Pulmonary   
Dyspnea143<1
Neurology   
Neuropathy—sensory13<10
Pain   
Pain, abdomen1120
Pain, headache10<10
Pain, joint1020
 Placebo (n=451)
Adverse Reaction
NCI-CTCAE v3.0
All grades (%)Grade 3 (%)Grade 4 (%)
Any adverse reaction86226
Gastrointestinal symptoms   
Diarrhea13<10
Nausea19<10
Anorexia1310
Vomiting1210
Constipation11<10
Dermatology/skin   
Rash/desquamation16<10
Hand-foot skin reaction700
Alopecia300
Pruritus600
Dry skin400
Constitutional symptoms   
Fatigue283<1
Weight loss600
Cardiovascular, general   
Hypertension2<10
Hemorrhage/bleeding   
Hemorrhageall sites81<1
Pulmonary   
Dyspnea122<1
Neurology   
Neuropathy—sensory6<10
Pain   
Pain, abdomen920
Pain, headache6<10
Pain, joint6<10
  • Most adverse reactions were Grades 1 and 2: NEXAVAR 57%, placebo 58%

  • Grades 3 and 4 adverse reactions occurred at rates of 31% and 7% with NEXAVAR, respectively, and 22% and 6% with placebo, respectively

  • Discontinuation of NEXAVAR due to adverse reactions was 10% vs 8% for placebo

Laboratory test abnormalities reported in TARGET1
 NEXAVAR (n=451)Placebo (n=451)
Laboratory Parameter NCI-CTCAE v3.0All grades
(%)
Grade 3 or 4
(%)
All grades
(%)
Grade 3 or 4
(%)
Hypophosphatemia4513113
Anemia442494
Elevated lipase4112307
Elevated amylase301233
Lymphopenia2313137
Neutropenia185102
Thrombocytopenia12150
Hypocalcemia1228<1
Hypokalemia51<1<1
 NEXAVAR (n=451)
Laboratory Parameter
NCI-CTCAE v3.0
All grades
(%)
Grade 3 or 4
(%)
Hypophosphatemia4513
Anemia442
Elevated lipase4112
Elevated amylase301
Lymphopenia2313
Neutropenia185
Thrombocytopenia121
Hypocalcemia122
Hypokalemia51
 Placebo (n=451)
Laboratory Parameter
NCI-CTCAE v3.0
All grades
(%)
Grade 3 or 4
(%)
Hypophosphatemia113
Anemia494
Elevated lipase307
Elevated amylase233
Lymphopenia137
Neutropenia102
Thrombocytopenia50
Hypocalcemia8<1
Hypokalemia<1<1

TARGET (Treatment Approaches in Renal Cancer Global Evaluation Trial): A randomized, double-blind, placebo-controlled, multicenter study in patients with advanced RCC who had received 1 prior systemic therapy (N=903).1,2

TARGET (Treatment Approaches in Renal Cancer Global Evaluation Trial): A randomized, double-blind, placebo-controlled, multicenter study in patients with advanced RCC who had received 1 prior systemic therapy (N=903).1,2

NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Reactions.

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