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Caprelsa(vandetanib)tablets(六)
2013-10-22 00:49:16 来源: 作者: 【 】 浏览:10703次 评论:0
een reported. [see Clinical Studies (14)]
Table 1 - Adverse Reactions in >10% of Patients on Vandetanib During Randomized Treatment
Preferred Term Vandetanib 300 mg N=231 Placebo N=99
*
Includes rash, rash erythematous, generalized, macular, maculo-papular, papular, pruritic, exfoliative, dermatitis, dermatitis bullous, generalized erythema and eczema.

Includes abdominal pain, abdominal pain upper, lower abdominal pain and abdominal discomfort

69% had QT prolongation >450ms and 7% had QT prolongation >500ms by ECG using Fridericia correction.

 All Grades
 Grade 3–4
 All Grades
 Grade 3–4
 
Diarrhea/Colitis
 132 (57%)
 26 (11%)
 27 (27%)
 2 (2%)
 
Rash*
 123 (53%)
 11 (5%)
 12 (12%)
 0
 
Dermatitis Acneiform/Acne
 81 (35%)
 2 (1%)
 7 (7%)
 0
 
Nausea
 77 (33%)
 2 (1%)
 16 (16%)
 0
 
Hypertension/Hypertensive Crisis/Accelerated Hypertension
 76 (33%)
 20 (9%)
 5 (5%)
 1 (1%)
 
Headache
 59 (26%)
 2 (1%)
 9 (9%)
 0
 
Fatigue
 55 (24%)
 13 (6%)
 23 (23%)
 1 (1%)
 
Decreased Appetite
 49 (21%)
 10 (4%)
 12 (12%)
 0
 
Abdominal Pain†
 48 (21%)
 6 (3%)
 11 (11%)
 0
 
Dry Skin
 35 (15%)
 0 5 (5%) 0
Vomiting
 34 (15%)
 2 (1%)
 7 (7%)
 0
Asthensia
 34 (15%)
 6 (3%)
 11 (11%)
 1 (1%)
ECG QT Prolonged‡
 33 (14%)
 18 (8%)
 1 (1%)
 1 (1%)
 
Photosensitivity Reaction
 31 (13%)
 4 (2%)
 0
 0
 
Insomnia
 30 (13%)
 0
 10 (10%)
 0
 
Nasopharyngitis
 26 (11%)
 0
 10 (10%)
 0
 
Dyspepsia
 25 (11%)
 0
 4 (4%)
 0
 
Hypocalcemia
 25 (11%)
 4 (2%)
 3 (3%) 0
Cough
 25 (11%)
 0
 10 (10%)
 0
 
Pruritus
 25 (11%)
 3 (1%)
 4 (4%)
 0
 
Weight Decreased
 24 (10%)
 2 (1%)
 9 (9%)
 0
 
Proteinuria
 23 (10%)
 0
 2 (2%)
 0
 
Depression
 22 (10%)
 4 (2%)
 3 (3%)
 0
Includes rash, rash erythematous, generalized, macular, maculo-papular, papular, pruritic, exfoliative, dermatitis, dermatitis bullous, generalized erythema and eczema.
Includes abdominal pain, abdominal pain upper, lower abdominal pain and abdominal discomfort
69% had QT prolongation >450ms and 7% had QT prolongation >500ms by ECG using Fridericia correction.
Adverse reactions resulting in death in patients receiving Vandetanib (N=5) were respiratory failure, respiratory arrest, aspiration pneumonia, cardiac failure with arrhythmia, and sepsis. Adverse reactions resulting in death in patients receiving placebo were gastrointestinal hemorrhage (1%)

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