|
ARRANON(nelarabine)Injection (十一)
|
|
0
|
8
|
|
Insomnia
|
0
|
0
|
7
|
|
Depression
|
1
|
0
|
6
|
|
Respiratory, Thoracic, and Mediastinal Disorders
|
|
Cough
|
0
|
0
|
25
|
|
Dyspnea
|
4
|
2
|
20
|
|
Pleural effusion
|
5
|
1
|
10
|
|
Epistaxis
|
0
|
0
|
8
|
|
Dyspnea, exertional
|
0
|
0
|
7
|
|
Wheezing
|
0
|
0
|
5
|
|
Vascular Disorders
|
|
Petechiae
|
2
|
0
|
12
|
|
Hypotension
|
1
|
1
|
8
|
Grade 4+ = Grade 4 and Grade 5
Five (5) patients had a fatal event. Fatal events included hypotension (n = 1), respiratory arrest (n = 1), pleural effusion/pneumothorax (n = 1), pneumonia (n = 1), and cerebral hemorrhage/coma/leukoencephalopathy (n = 1). The cerebral hemorrhage/coma/leukoencephalopathy was thought to be related to treatment with ARRANON. All other fatal events were unrelated to treatment with ARRANON.
Other Adverse Events
Blurred vision was also reported in 4% of adult patients.
There was a single report of biopsy confirmed progressive multifocal leukoencephalopathy in the adult patient population.
There have been reports of sometimes fatal opportunistic infections in patients receiving ARRANON.
Neurologic Adverse Events
Nervous system events, regardless of drug relationship, were reported for 64% of patients across the Phase I and Phase II studies.
Pediatric: The most common neurologic adverse events (≥2%), regardless of causality, including all grades (NCI Common Toxicity Criteria) are shown in Table 6 for pediatric patients.
Table 6. Neurologic Adverse Events (≥2%) Regardless of Causality in Pediatric Patients Treated with 650 mg/m2 of ARRANON Administered Intravenously Over 1 Hour Daily for 5 Consecutive Days Repeated Every 21 Days
|
Nervous System Disorders
Preferred Term
|
Percentage of Patients; N = 84
|
|
Grade 1
%
|
Grade 2
%
|
Grade 3
%
|
Grade 4+
%
|
All Grades
%
|
|
Headache
|
|
|
