|
TOP
|
|
GLIADEL® Wafer(六)
|
|
Intracranial hypertension |
11 (9) |
2 (2) |
|
Personality disorder |
10 (8) |
9 (8) |
|
Anxiety |
8 (7) |
5 (4) |
|
Facial paralysis |
8 (7) |
5 (4) |
|
Neuropathy |
8 (7) |
12 (10) |
|
Ataxia |
7 (6) |
5 (4) |
|
Hypesthesia |
7 (6) |
6 (5) |
|
Paresthesia |
7 (6) |
10 (8) |
|
Thinking abnormal |
7 (6) |
10 (8) |
|
Abnormal gait |
6 (5) |
6 (5) |
|
Dizziness |
6 (5) |
11 (9) |
|
Grand mal convulsion |
6 (5) |
5 (4) |
|
Hallucinations |
6 (5) |
4 (3) |
|
Insomnia |
6 (5) |
7 (6) |
|
Tremor |
6 (5) |
8 (7) |
|
Coma |
5 (4) |
6 (5) |
|
Incoordination |
3 (3) |
8 (7) |
|
Hypokinesia |
2 (2) |
8 (7) |
|
Respiratory system |
|
Pneumonia |
10 (8) |
9 (8) |
|
Dyspnea |
4 (3) |
8 (7) |
|
Skin and appendages |
|
Rash |
14 (12) |
13 (11) |
|
Alopecia |
12 (10) |
14 (12) |
|
Special senses |
|
Conjunctival edema |
8 (7) |
8 (7) |
|
Abnormal vision |
7 (6) |
7 (6) |
|
Visual field defect |
6 (5) |
8 (7) |
|
Eye disorder |
3 (3) |
6 (5) |
|
Diplopia |
1 (1) |
6 (5) |
|
Urogenital system |
|
Urinary tract infection |
10 (8) |
13 (11) |
|
Urinary incontinence |
9 (8) |
9 (8) |
*Adverse events coded to the COSTART term "aggravation reaction" were usually events involving tumor/disease progression or general deterioration of condition (e.g. condition/health/Karnofsky/neurological/physical deterioration).
Surgery for Recurrent Disease
The following post-operative adverse events were observed in 4% or more of the patients receiving GLIADEL® Wafer at recurrent surgery. Except for nervous system effects, where there is a possibility that the placebo wafers could have been responsible, only events more common in the GLIADEL® Wafer group are listed. These adverse events |
