|
|
Metabolism and nutrition disorders
|
very common
|
Healing abnormal
|
|
common
|
Hyponatraemia
|
|
Nervous system disorders
|
very common
|
Convulsion, hemiplegia, headache, somnolence, confusion
|
|
common
|
Aphasia, stupor, brain oedema, intracranial hypertension, meningitis or abscess
|
|
Cardiac disorders
|
common
|
Deep thrombophlebitis, Pulmonary embolism
|
|
Respiratory, thoracic and mediastinal disorders
|
common
|
Pneumonia
|
|
Gastrointestinal disorders
|
common
|
Nausea, nausea and vomiting, oral moniliasis
|
|
Skin and subcutaneous tissue disorders
|
common
|
Rash
|
|
Renal and urinary disorders
|
very common
|
Urinary tract infection
|
|
General disorders and administration site conditions
|
very common
|
Fever
|
|
common
|
Infection, pain
|
The following adverse events, not listed in the table above, were reported in less than 4% but at least 1% of patients treated with GLIADEL Implant in all studies. The events listed were either not present pre-operatively or worsened post-operatively. Whether GLIADEL Implant caused these events cannot be determined.
Common Adverse Events in 1% to 4% of Patients Receiving GLIADEL Implant
|
Class organ
|
Adverse events
|
|
Blood and lymphatic system disorders
|
common
|
Thrombocytopenia, leukocytosis
|
|
Metabolism and nutrition disorders
|
common
|
Hyponatraemia, hyperglycaemia, hypokalaemia
|
|
Nervous system disorders
|
common
|
Hydrocephalus, depression, abnormal thinking, ataxia, dizziness, insomnia, hemiplegia, coma, amnesia, diplopia, paranoid reaction
|
|
uncommon
|
Cerebral haemorrhage, cerebral infarct
|
|
Eye Disorders
|
common
|
Visual defect, eye pain
|
|
Cardiac and vascular Disorders
|
common
|
Hypertension, hypotension
|
|
Respiratory, thoracic and mediastinal disorders
|
common
|
Infection, aspiration pneumonia
|
|
Gastrointestinal disorders
|
common
|
Diarrhoea, constipation, dysphagia, gastrointestinal haemorrhage, faecal inc
|
