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KYMRIAH(tisagenlecleuce)suspension for intravenous infusion(十一)
2018-06-22 03:24:27 来源: 作者: 【 】 浏览:12828次 评论:0
ory distress, respiratory failure. 
nRash includes rash, rash maculo-papular, rash papular, and rash pruritic. 
Adverse Reaction All Grades 
(%) Grades 3 or Higher 
(%) 
Blood and lymphatic system disorders   
     Febrile Neutropenia 37 37 
Cardiac disorders   
    aTachycardia 26 4 
Gastrointestinal disorders   
    Nausea 26 3 
    Diarrhea 26 1 
    Vomiting 26 1 
    Constipation 18 0 
    bAbdominal pain 16 3 
General disorders and administration site conditions   
    Pyrexia 40 15 
    cFatigue 25 0 
    dEdema 21 1 
    Chills 10 0 
    ePain 18 3 
Immune system disorders   
    Cytokine release syndrome 79 49 
    fHypogammaglobulinemia 43 7 
Infections and infestations   
    Infections-pathogen unspecified 41 16 
    Viral infectious disorders 26 18 
    Bacterial infectious disorders 19 13 
    Fungal infectious disorders 13 7 
Investigations   
    International normalized ratio increased 13 0 
Metabolism and nutrition disorders   
    Decreased appetite 37 15 
    Fluid overload 10 7 
Musculoskeletal and connective tissue disorders   
    Myalgia 15 0 
    Arthralgia 12 1 
    Back pain 10 3 
Nervous system disorders   
    gHeadache 37 3 
    hEncephalopathy 34 10 
Psychiatric disorders   
    iDelirium 21 4 
    Anxiety 13 3 
    jSleep disorders 10 0 
Renal and urinary disorders   
    kAcute kidney injury 24 15 
Respiratory, thoracic and mediastinal disorders   
    Hypoxia 24 18 
    lCough 21 0 
    mDyspnea 16 12 
    Pulmonary edema 16 10 
    Tachypnea 12 6 
    Pleural effusion 10 4 
    Nasal congestion 10 0 
Skin and subcutaneous tissue disorders   
    nRash 16 1 
Vascular disorders   
    Hypotension 31 22 
    Hypertension 19 6 
aSpeech disorder includes aphasia and dysarthria. 
bMotor dysfunction includes muscle spasms. 
Additional important adverse reactions that did not meet the threshold criteria for inclusion in Table 2 were: 
Blood and lymphatic system disorders: disseminated intravascular coagulation (9%), histiocytosis lymphocytic hemophagocytosis (7%), coagulopathy (6%), Grade 3 and Grade 4 hypofibrinogenemia with Grade 3 and 4 CRS (16%)  
Cardiac Disorders: cardiac arrest (4%), cardiac failure (7%)  
Gastrointestinal disorders: abdominal compartment syndrome (1%)&n
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