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 reaction | 95 | 31 | 7 | 86 | 22 | 6 |
Gastrointestinal symptoms | ||||||
Diarrhea | 43 | 2 | 0 | 13 | <1 | 0 |
Nausea | 23 | <1 | 0 | 19 | <1 | 0 |
Anorexia | 16 | <1 | 0 | 13 | 1 | 0 |
Vomiting | 16 | <1 | 0 | 12 | 1 | 0 |
Constipation | 15 | <1 | 0 | 11 | <1 | 0 |
Dermatology/skin | ||||||
Rash/desquamation | 40 | <1 | 0 | 16 | <1 | 0 |
Hand-foot skin reaction | 30 | 6 | 0 | 7 | 0 | 0 |
Alopecia | 27 | <1 | 0 | 3 | 0 | 0 |
Pruritus | 19 | <1 | 0 | 6 | 0 | 0 |
Dry skin | 11 | 0 | 0 | 4 | 0 | 0 |
Constitutional symptoms | ||||||
Fatigue | 37 | 5 | <1 | 28 | 3 | <1 |
Weight loss | 10 | <1 | 0 | 6 | 0 | 0 |
Cardiovascular, general | ||||||
Hypertension | 17 | 3 | <1 | 2 | <1 | 0 |
Hemorrhage/bleeding | ||||||
Hemorrhage—all sites | 15 | 2 | 0 | 8 | 1 | <1 |
Pulmonary | ||||||
Dyspnea | 14 | 3 | <1 | 12 | 2 | <1 |
Neurology | ||||||
Neuropathy—sensory | 13 | <1 | 0 | 6 | <1 | 0 |
Pain | ||||||
Pain, abdomen | 11 | 2 | 0 | 9 | 2 | 0 |
Pain, headache | 10 | <1 | 0 | 6 | <1 | 0 |
Pain, joint | 10 | 2 | 0 | 6 | <1 | 0 |
NEXAVAR (n=451) | |||
---|---|---|---|
Adverse Reaction NCI-CTCAE v3.0 | All grades (%) | Grade 3 (%) | Grade 4 (%) |
Any adverse reaction | 95 | 31 | 7 |
Gastrointestinal symptoms | |||
Diarrhea | 43 | 2 | 0 |
Nausea | 23 | <1 | 0 |
Anorexia | 16 | <1 | 0 |
Vomiting | 16 | <1 | 0 |
Constipation | 15 | <1 | 0 |
Dermatology/skin | |||
Rash/desquamation | 40 | <1 | 0 |
Hand-foot skin reaction | 30 | 6 | 0 |
Alopecia | 27 | <1 | 0 |
Pruritus | 19 | <1 | 0 |
Dry skin | 11 | 0 | 0 |
Constitutional symptoms | |||
Fatigue | 37 | 5 | <1 |
Weight loss | 10 | <1 | 0 |
Cardiovascular, general | |||
Hypertension | 17 | 3 | <1 |
Hemorrhage/bleeding | |||
Hemorrhage—all sites | 15 | 2 | 0 |
Pulmonary | |||
Dyspnea | 14 | 3 | <1 |
Neurology | |||
Neuropathy—sensory | 13 | <1 | 0 |
Pain | |||
Pain, abdomen | 11 | 2 | 0 |
Pain, headache | 10 | <1 | 0 |
Pain, joint | 10 | 2 | 0 |
Placebo (n=451) | |||
---|---|---|---|
Adverse Reaction NCI-CTCAE v3.0 | All grades (%) | Grade 3 (%) | Grade 4 (%) |
Any adverse reaction | 86 | 22 | 6 |
Gastrointestinal symptoms | |||
Diarrhea | 13 | <1 | 0 |
Nausea | 19 | <1 | 0 |
Anorexia | 13 | 1 | 0 |
Vomiting | 12 | 1 | 0 |
Constipation | 11 | <1 | 0 |
Dermatology/skin | |||
Rash/desquamation | 16 | <1 | 0 |
Hand-foot skin reaction | 7 | 0 | 0 |
Alopecia | 3 | 0 | 0 |
Pruritus | 6 | 0 | 0 |
Dry skin | 4 | 0 | 0 |
Constitutional symptoms | |||
Fatigue | 28 | 3 | <1 |
Weight loss | 6 | 0 | 0 |
Cardiovascular, general | |||
Hypertension | 2 | <1 | 0 |
Hemorrhage/bleeding | |||
Hemorrhage—all sites | 8 | 1 | <1 |
Pulmonary | |||
Dyspnea | 12 | 2 | <1 |
Neurology | |||
Neuropathy—sensory | 6 | <1 | 0 |
Pain | |||
Pain, abdomen | 9 | 2 | 0 |
Pain, headache | 6 | <1 | 0 |
Pain, joint | 6 | <1 | 0 |
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
NEXAVAR (n=451) | Placebo (n=451) | |||
---|---|---|---|---|
Laboratory Parameter NCI-CTCAE v3.0 | All grades (%) | Grade 3 or 4 (%) | All grades (%) | Grade 3 or 4 (%) |
Hypophosphatemia | 45 | 13 | 11 | 3 |
Anemia | 44 | 2 | 49 | 4 |
Elevated lipase | 41 | 12 | 30 | 7 |
Elevated amylase | 30 | 1 | 23 | 3 |
Lymphopenia | 23 | 13 | 13 | 7 |
Neutropenia | 18 | 5 | 10 | 2 |
Thrombocytopenia | 12 | 1 | 5 | 0 |
Hypocalcemia | 12 | 2 | 8 | <1 |
Hypokalemia | 5 | 1 | <1 | <1 |
NEXAVAR (n=451) | ||
---|---|---|
Laboratory Parameter NCI-CTCAE v3.0 | All grades (%) | Grade 3 or 4 (%) |
Hypophosphatemia | 45 | 13 |
Anemia | 44 | 2 |
Elevated lipase | 41 | 12 |
Elevated amylase | 30 | 1 |
Lymphopenia | 23 | 13 |
Neutropenia | 18 | 5 |
Thrombocytopenia | 12 | 1 |
Hypocalcemia | 12 | 2 |
Hypokalemia | 5 | 1 |
Placebo (n=451) | ||
---|---|---|
Laboratory Parameter NCI-CTCAE v3.0 | All grades (%) | Grade 3 or 4 (%) |
Hypophosphatemia | 11 | 3 |
Anemia | 49 | 4 |
Elevated lipase | 30 | 7 |
Elevated amylase | 23 | 3 |
Lymphopenia | 13 | 7 |
Neutropenia | 10 | 2 |
Thrombocytopenia | 5 | 0 |
Hypocalcemia | 8 | <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
NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Reactions.