NOVOCURE MEDICAL OPINION IS THAT ALTHOUGH THE PRESCRIBER ASSESSED THIS EVENT AS NOT RELATED TO OPTUNE, A CONTRIBUTION OF ARRAY PLACEMENT TO THE EVENTS OF WOUND INFECTION AND WOUND DEHISCENCE CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR WOUND DEHISCENCE/WOUND INFECTION IN THIS PATIENT ALSO INCLUDE PRIOR RADIATION, CHEMOTHERAPY, AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. WOUND DEHISCENCE 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 THE OPTUNE/TMZ ARM OF THE TRIAL (
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Patient 1
A (B)(6) FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT REPORTED THAT SHE HAD RECENTLY HAD SKIN GRAFT ON THE TOP OF HER HEAD. PER HOSPITAL SUMMARY, PATIENT UNDERWENT WOUND REVISION SURGERY ON (B)(6) 2018 DUE TO PERSISTENT WOUND INFECTION AND WOUND DEHISCENCE FROM HER PREVIOUS RESECTION SURGERY ((B)(6) 2017) AND PROGRAMMABLE VALVE PLACEMENT ((B)(6) 2017). PATIENT WAS DISCHARGED ON AN UNKNOWN DATE WITH JP DRAIN IN PLACE AND OPTUNE TREATMENT CONTINUED. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED WITH HEADACHES, MEMORY PROBLEMS, NECK STIFFNESS AND PHOTOPHOBIA. LUMBAR PUNCTURE (LP) AT ADMISSION SHOWED AN OPENING PRESSURE OF 14 AND A CLOSING PRESSURE OF 4 AFTER 8 CC FLUID REMOVAL. REPEAT LP SHOWED AN OPENING PRESSURE OF 11 AND 15 CC FLUID WAS REMOVED. THERE WAS CONCERN FOR POSSIBLE SHUNT INFECTION, BUT ALL CULTURES WERE NEGATIVE AND INCISION APPEARED TO BE HEALING NORMALLY. JP DRAIN WAS REMOVED. PATIENT WAS DISCHARGED ON (B)(6) 2018 IN IMPROVED CONDITION WITH A PLAN FOR REPEAT LP IN ONE WEEK. THE PRESCRIBING PHYSICIAN STATED THAT THE EVENTS WERE NOT RELATED TO OPTUNE THERAPY.