|
8
|
2
|
4
|
2
|
17
|
|
Peripheral neurologic disorders, any event
|
1
|
4
|
7
|
0
|
12
|
|
Peripheral neuropathy
|
0
|
4
|
2
|
0
|
6
|
|
Peripheral motor neuropathy
|
1
|
0
|
2
|
0
|
4
|
|
Peripheral sensory neuropathy
|
0
|
0
|
6
|
0
|
6
|
|
Somnolence
|
1
|
4
|
1
|
1
|
7
|
|
Hypoesthesia
|
1
|
1
|
4
|
0
|
6
|
|
Seizures
|
0
|
0
|
0
|
6
|
6
|
|
Convulsions
|
0
|
0
|
0
|
3
|
4
|
|
Grand mal convulsions
|
0
|
0
|
0
|
1
|
1
|
|
Status epilepticus
|
0
|
0
|
0
|
1
|
1
|
|
Motor dysfunction
|
1
|
1
|
1
|
0
|
4
|
|
Nervous system disorder
|
1
|
2
|
0
|
0
|
4
|
|
Paresthesia
|
0
|
2
|
1
|
0
|
4
|
|
Tremor
|
1
|
2
|
0
|
0
|
4
|
|
Ataxia
|
1
|
0
|
1
|
0
|
2
|
One (1) patient had a fatal neurologic event, status epilepticus. This event was thought to be related to treatment with ARRANON.
The other grade 3 event in pediatric patients, regardless of causality, was hypert
