Novocure's opinion is that a contribution of the array placement to the event cannot be ruled out.Contributing factors for wound infection in this patient also include, prior radiation, chemotherapy, 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).
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A (b)(6) female patient with newly diagnosed glioblastoma began optune therapy on (b)(6) 2018, as part of the ist "spare-scalp preservation and radiation plus alternating electric tumor treatment field (novottf-200a, optune) for patients with glioblastoma: a pilot study".On october 21, 2019, novocure was informed that the patient had developed a skin irritation on the scalp and applied topical steroid (clobetasol) and nonsteroidal (tetrix) creams to the affected area.Optune therapy was temporarily discontinued.The patient subsequently developed a pruritic pus filled area on the surgical resection site (last resection (b)(6) 2018).Prescribing physician was informed and started patient on a 14 day antibiotic course, however, the infection worsened.On an unspecified date, patient was hospitalized and underwent wound revision surgery.Optune therapy was permanently discontinued.Prescribing physician was contacted for additional information and causality assessment with no response.
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