were either not present pre-operatively or worsened post-operatively during the follow-up period. The follow-up period was up to 71 months.
COMMON ADVERSE EVENTS OBSERVED IN ≥ 4% OF PATIENTS RECEIVING GLIADEL® WAFER AT SURGERY FOR RECURRENT DISEASE
Body System
Adverse Event |
GLIADEL® Wafer with Carmustine
[N=110]
n (%) |
PLACEBO Wafer without Carmustine
[N=112]
n (%) |
|
*p < 0.05 for comparison of GLIADEL® Wafer versus placebo groups |
|
Body as a Whole |
|
Fever |
13 (12) |
9 (8) |
|
Pain* |
8 (7) |
1 (1) |
|
Digestive System |
|
Nausea and Vomiting |
9 (8) |
7 (6) |
|
Metabolic and Nutritional Disorders |
|
Healing Abnormal* |
15 (14) |
6 (5) |
|
Nervous System |
|
Convulsion |
21 (19) |
21 (19) |
|
Hemiplegia |
21 (19) |
22 (20) |
|
Headache |
16 (15) |
14 (13) |
|
Somnolence |
15 (14) |
12 (11) |
|
Confusion |
11 (10) |
9 (8) |
|
Aphasia |
10 (9) |
12 (11) |
|
Stupor |
7 (6) |
7 (6) |
|
Brain Edema |
4 (4) |
1 (1) |
|
Intracranial Hypertension |
4 (4) |
7 (6) |
|
Meningitis or Abscess |
4 (4) |
1 (1) |
|
Skin and Appendages |
|
Rash |
6 (5) |
4 (4) |
|
Urogenital System |
|
Urinary Tract Infection |
23 (21) |
19 (17) |
Post-marketing experience includes spontaneous reports of cyst formation after GLIADEL® wafer implantation. These occurred at varying time intervals post-implantation. Cyst formation has also been reported in patients following resection of malignant glioma who have not had Gliadel® implanted.
The following four categories of adverse events are possibly related to treatment with GLIADEL® Wafer. The frequency with which they occurred in the randomized trials along with descriptive detail is provided below.
1. Seizures: In the initial surgery trial, the incidence of seizures was 33.3% in patients receiving GLIADEL® Wafer and 37.5% in patients receiving placebo. Grand mal seizures occurred in 5% of GLIADEL® Wafer-treated patients and 4.2% of placebo treated patients. The incidence of seizures within the first 5 days after wafer implantation was 2.5% in the GLIADEL® Wafer group and 4.2% in the placebo group. The time from surgery to the onset of the first post-operative seizure did not differ between the GLIADEL® Wafer and placebo treated patients.
In the surgery for recurrent disease t
