ial 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
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 at Recurrent Surger
Class organ
Adverse events
Blood and lymphatic system disorders
common
Anaemia
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 ca |
