onia reported in 1 patient (1%). The additional grade 4+ events, regardless of causality, were 3rd nerve paralysis, and 6th nerve paralysis, each reported in 1 patient (1%).
The other neurologic adverse events, regardless of causality, reported as grade 1, 2, or unknown in pediatric patients were dysarthria, encephalopathy, hydrocephalus, hyporeflexia, lethargy, mental impairment, paralysis, and sensory loss, each reported in 1 patient (1%).
Adults: The most common neurologic adverse events (≥2%), regardless of causality, including all grades (NCI Common Toxicity Criteria) are shown in Table 7 for adult patients.
Table 7. Neurologic Adverse Events (≥2%) 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
|
Nervous System Disorders
Preferred Term
|
Percentage of Patients; N =103
|
|
Grade 1
%
|
Grade 2
%
|
Grade 3
%
|
Grade 4
%
|
All Grades
%
|
|
Somnolence
|
20
|
3
|
0
|
0
|
23
|
|
Dizziness
|
14
|
8
|
0
|
0
|
21
|
|
Peripheral neurologic disorders, any event
|
8
|
12
|
2
|
0
|
21
|
|
Neuropathy
|
0
|
4
|
0
|
0
|
4
|
|
Peripheral neuropathy
|
2
|
2
|
1
|
0
|
5
|
|
Peripheral motor neuropathy
|
3
|
3
|
1
|
0
|
7
|
|
Peripheral sensory neuropathy
|
7
|
6
|
0
|
0
|
13
|
|
Hypoesthesia
|
5
|
10
|
2
|
0
|
17
|
|
Headache
|
11
|
3
|
1
|
0
|
15
|
|
Paresthesia
|
11
|
4
|
0
|
0
|
15
|
|
Ataxia
|
1
|
6
|
2
|
0
|
