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INLYTA (axitinib) tablet(六)
2013-10-05 17:12:39 来源: 作者: 【 】 浏览:10611次 评论:0
14
2 11 1
Headache 14 1 11 0
Pain in extremity 13 1 14 1
Rash 13 <1 32 4
Proteinuria 11 3 7 2
Dysgeusia 11 0 8 0
Dry skin 10 0 11 0
Dyspepsia 10 0 2 0
Pruritus 7 0 12 0
Alopecia 4 0 32 0
Erythema 2 0 10 <1 

Selected adverse reactions (all grades) that were reported in <10% of patients treated with Inlyta included dizziness (9%), upper abdominal pain (8%), myalgia (7%), dehydration (6%), epistaxis (6%), anemia (4%), hemorrhoids (4%), hematuria (3%), tinnitus (3%), lipase increased (3%), pulmonary embolism (2%), rectal hemorrhage (2%), hemoptysis (2%), deep vein thrombosis (1%), retinal-vein occlusion/thrombosis (1%), polycythemia (1%), transient ischemic attack (1%), and RPLS (<1%).
Table 2 presents the most common laboratory abnormalities reported in ≥10% patients who received Inlyta or sorafenib.
Table 2. Laboratory Abnormalities Occurring in ≥10% of Patients Who Received Inlyta or Sorafenib
 

Laboratory Abnormality N Inlyta N Sorafenib
All Grades* Grade 3/4 All Grades* Grade 3/4
% % % %
ALP: alkaline phosphatase; ALT: alanine aminotransferase; AST: aspartate aminotransferase

National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0

Hematology            
Hemoglobin decreased 320 35 <1 316 52 4
Lymphocytes (absolute) decreased 317 33 3 309 36 4
Platelets decreased 312 15 <1 310 14 0
White blood cells decreased 320 11 0 315 16 <1
Chemistry            
Creatinine increased 336 55 0 318 41 <1
Bicarbonate decreased 314 44 <1 291 43 0
Hypocalcemia 336 39 1
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