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ARRANON(nelarabine)Injection (九)
2013-10-12 18:41:16 来源: 作者: 【大 中 小】 浏览:10134次 评论:0条
(see Table 6)

Gastrointestinal Disorders

Vomiting

0

0

10

General Disorders & Administration Site Conditions

Asthenia

1

0

6

Infections& Infestations

Infection

2

1

5

Grade 4+ = Grade 4 and Grade 5

Three (3) patients had a fatal event. Fatal events included neutropenia and pyrexia (n = 1), status epilepticus/seizure (n = 1), and fungal pneumonia (n = 1). The status epilepticus was thought to be related to treatment with ARRANON. All other fatal events were unrelated to treatment with ARRANON.

Table 5. Most Commonly Reported (≥5% Overall) Adverse Events Regardless of Causality in Adult Patients Treated with 1,500 mg/m2 of ARRANON Administered Intravenously Over 2 Hours on Days 1, 3, and 5 Repeated Every 21 Days

System Organ Class

Preferred Term

Percentage of Patients; N = 103

Toxicity Grade

Grade 3

%

Grade 4+

%

All Grades

%

Blood and Lymphatic System Disorders

Anemia

20

14

99

Thrombocytopenia

37

22

86

Neutropenia

14

49

81

Febrile neutropenia

9

1

12

Cardiac Disorders

Sinus tachycardia

1

0

8

Gastrointestinal Disorders

Nausea

0

0

41

Diarrhea

1

0

22

Vomiting

1

0

22

Constipation

1

0

21

Abdominal pain

1

0

9

Stomatitis

1

0

8

Abdominal distension

0

0

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