|
common
|
Peripheral oedema
|
|
Nervous system disorders
|
very common
|
Hemiplegia, convulsion, confusion, brain oedema, aphasia, depression, somnolence, speech disorder
|
|
common
|
Amnesia, intracranial hypertension, personality disorder, anxiety, facial paralysis, neuropathy, ataxia, hypoesthesia, paresthesia, thinking abnormal, abnormal gait, dizziness, grand mal convulsion, hallucinations, insomnia, tremor
|
|
Eye disorders
|
common
|
Conjonctival oedema, abnormal vision, visual field defect
|
|
Cardiac disorders
|
very common
|
Deep thrombophlebitis
|
|
common
|
Pulmonary embolism, haemorrhage
|
|
Respiratory, thoracic and mediastinal disorders
|
common
|
Pneumonia
|
|
Gastrointestinal disorders
|
very common
|
Nausea, vomiting, constipation
|
|
common
|
Diarrhoea
|
|
Skin and subcutaneous tissue disorders
|
very common
|
Rash, alopecia
|
|
Renal and urinary disorders
|
common
|
Urinary tract infection, urinary incontinence
|
|
General disorders and administration site conditions
|
very common
|
Aggravation reaction, headache, asthenia, infection, fever, pain
|
|
common
|
Abdominal pain, back pain, face oedema, chest pain, abscess, accidental injury
|
Intracranial hypertension was present in more GLIADEL Implant-treated patients than in Placebo patients (9.2% vs. 1.7%). It was typically observed late, at the time of tumour recurrence, and was unlikely to be associated with GLIADEL Implant use (see section 4.4).
CSF leak was more common in GLIADEL Implant-treated patients than in placebo patients. However intracranial infections and other healing abnormalities were not increased (see section 4.4).
Surgery for Recurrent Disease
The following post-operative adverse events were observed in 4% or more of the 110 patients receiving GLIADEL Implant at recurrent surgery in a controlled clinical trial. Except for nervous system effects, where there is a possibility that the placebo implants could have been responsible, only events more common in the GLIADEL Implant 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 in ≥4% of Patients Receiving GLIADEL Implant atRecurrent Surgery
|
Class organ
|
Adverse events
|
|
Blood and lymphatic system disorders
|
common
|
Anaemia
|
