Novocure opinion is that the contribution of the array placement to wound dehiscence and wound infection cannot be ruled out.Contributing factors for wound infection and wound dehiscence in this patient include: prior dexamethasone use (impaired wound healing and increased risk of infection are listed as side effects.Source: dexamethasone prescribing information), concomitant bevacizumab (carries a black box warning for wound complications.Source: bevacizumab prescribing information), prior radiation, underlying cancer disease, and prior surgery affecting skin integrity.Wound infection is an expected event with device use and was reported as an adverse event in the ef-14 trial of optune together with temozolomide (tmz) compared to tmz alone in patients with newly diagnosed gbm in both arms of the trial (<1% and <1% in optune/tmz and tmz arms respectively).Wound dehiscence was reported in the ef-14 trial in the optune/tmz arm of the trial (<1%) only.
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A 64-year-old female patient with newly diagnosed glioblastoma (gbm) began optune therapy on (b)(6) 2023.Novocure was informed by the patient's spouse on (b)(6) 2023, that the patient's surgical resection site was infected and surgical intervention was needed.Optune therapy was temporarily discontinued on (b)(6), 2023.On (b)(6), 2023, the spouse reported that the patient continued to experience unspecified complications and sutures remained on her scalp.The incision site reportedly, opened and unspecified antibiotics were prescribed for six days.The prescribing physician did not provide a causality assessment.
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