on 2 (2) 6 (5)
Cardiovascular system
Deep thrombophlebitis 12 (10) 11 (9)
Pulmonary embolus 10 (8) 10 (8)
Hemorrhage 8 (7) 7 (6)
Digestive system
Nausea 26 (22) 20 (17)
Vomiting 25 (21) 19 (16)
Constipation 23 (19) 14 (12)
Diarrhea 6 (5) 5 (4)
Liver function tests abnormal 1 (1) 6 (5)
Endocrine system
Diabetes mellitus 6 (5) 5 (4)
Cushings syndrome 4 (3) 6 (5)
Metabolic and nutritional disorders
Healing abnormal 19 (16) 14 (12)
Peripheral edema 11 (9) 11 (9)
Musculoskeletal system
Myasthenia 5 (4) 6 (5)
Nervous system
Hemiplegia 49 (41) 53 (44)
Convulsion 40 (33) 45 (38)
Confusion 28 (23) 25 (21)
Brain edema 27 (23) 23 (19)
Aphasia 21 (18) 22 (18)
Depression 19 (16) 12 (10)
Somnolence 13 (11) 18 (15)
Speech disorder 13 (11) 10 (8)
Amnesia 11 (9) 12 (10)
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)
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 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
Heal
