Novocure medical opinion is that a contribution of the array placement to the event cannot be ruled out.Other contributing factors for skin erosion 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 is listed as a side effect.Source: dexamethasone prescribing information), underlying cancer disease, prior radiation and prior surgery affecting skin integrity.Skin erosion leading to vp shunt revision was not reported in the ef-11 pivotal trial in recurrent glioblastoma or in the commercial program to date.The optune instructions for use cautions that use of the device with implanted medical devices in the brain may lead to tissue damage.Scalp necrosis is a known complication of vp shunt placement.Vp shunt complications have been reported in the literature as occurring in 11.8% of patients with brain tumors, with 6.7% of patients requiring shunt removal (source: nigim et al, oncology, 2015, 3:1381-1386).
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Patient with recurrent glioblastoma on bevacizumab plus nivolumab began optune therapy on (b)(6) 2016.On (b)(6) 2016, patient developed a skin reaction (described as "sores") and temporarily discontinued optune therapy.Patient was not hospitalized or medically treated for the event.On (b)(6) 2016, the patient resumed optune therapy.On july 7, 2015, novocure was informed by the prescribing site nurse that the patient had experienced skin erosion near the area of her ventriculoperitoneal (vp) shunt (inserted on (b)(6) 2015).Optune therapy was discontinued.Vp shunt was removed on (b)(6) 2016.Wound and blood cultures were negative.Patient was seen at the prescriber's clinic on (b)(6) 2016 and the surgical site was healing.Prescriber assessed the event as related to optune therapy.
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