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Campath-FDA批准治疗B细胞性慢性淋巴细胞性白血病新药(九)
2013-10-29 23:05:21 来源: 作者: 【 】 浏览:7183次 评论:0
nbsp;   Stomatitis, Ulcerative Stomatitis, Mucositis 14 1
        Abdominal Pain 11 2
        Dyspepsia 10 --
        Constipation 9 1
Hematologic Disorders   
        WBC Disorders: Neutropenia 85 64
        RBC Disorders: Anemia 80 38
Pancytopenia 5 3
Platelet, Bleeding & Clotting Disorders:   
        Thrombocytopenia 72 50
        Purpura 8 --
        Epistaxis 7 1
Musculoskeletal Disorders   
        Myalgias 11 --
Psychiatric Disorders   
        Insomnia 10 --
        Depression 7 1
        Somnolence 5 1
Resistance Mechanism Disorders   
        Sepsis 15 10
        Herpes Simplex 11 1
        Moniliasis 8 1
        Infection (other viral or unidentified) 7 1
Respiratory System Disorders    
        Dyspnea 26 9
        Cough 25 2
        Bronchitis, Pneumonitis 21 13
        Pneumonia 16 10
        Pharyngitis 12 --
        Bronchospasm 9 2
        Rhinitis 7 --
Skin & Appendage Disorders    
        Rash, Maculopapular Rash, Erythematous Rash 40 3
        Urticaria 30 5
        Pruritus 24 1
        Sweating increased 19 1
Serious adverse events:
The following serious adverse events, defined as events which result in death, requiring or prolonging hospitalization, requiring medical intervention to prevent hospitalization, or malignancy, were reported in at least one patient treated on studies where Campath was used as a single agent (and are not reported in Table 2). These studies were conducted in patients with lymphocytic leukemia and lymphoma (N = 745) and in patients with non-malignant diseases (N =152) such as rheumatoid arthritis, solid organ transplant, or multiple sclerosis.
Body As A Whole: allergic reactions, anaphylactoid reaction, ascites, hypovolemia, influenza-like syndrome, mouth edema, neutropenic fever, syncope
Cardiovascular Disorders: cardiac failure, cyanosis, atrial fibrillation, cardiac arrest, ventricular arrhythmia, ventricular tachycardia, angina pectoris, coronary artery disorder, myocardial infarction, pericarditis
Central and Peripheral Nervous System Disorders: abnormal gait, aphasia, coma, grand mal convulsions, para
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上一篇抗白血病新药"Campath".. 下一篇FDA批准无鸡蛋成分的重组Flublok..

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