Novocure agrees with the prescribing physician that the events were not related to optune therapy.Other contributing factors for wound infection, wound dehiscence and resulting brain abscess in this patient include: concomitant bevacizumab (vegf inhibitor which carries a black box warning for wound healing complications.Source: bevacizumab prescribing information), concomitant dexamethasone (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), advanced age (b)(6), warfarin use, underlying cancer disease, prior radiation and prior surgery affecting skin integrity.Brain abscess, wound infection and wound dehiscence were not reported as adverse events in the ef-11 recurrent gbm pivotal trial.There have been 4 reports of abscesses, 15 reports of wound infection, and 19 reports of wound dehiscence in the commercial program to date.
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Patient with recurrent glioblastoma began optune therapy on (b)(6) 2016.On (b)(6) 2016, patient's daughter reported patient was hospitalized due to an open wound with dehiscence at the site of the patient's previous surgical resection scar (resection on (b)(6) 2016).Per discharge summary, patient was admitted (b)(6) 2016 for wound dehiscence and suspected abscess of the brain.Patient underwent repeat craniotomy and drainage of brain abscess x2 on (b)(6) 2016, respectively.Deep wound cultures were positive for moraxella catarrhalis, beta lactamase, and propionibacterium acnes.Brain mri conducted on (b)(6) 2016 was stable when compared to previous mri conducted on (b)(6) 2016.Patient went on a 56 day course antibiotics (ceftriaxone) to treat infection and was discharged in good condition to a skilled nursing facility for short term rehabilitation on (b)(6) 2016.Per prescribing physician, the events were caused by skin breakdown and wound dehiscence due to concomitant bevacizumab usage.Physician stated the events were unlikely caused by optune therapy.
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