BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOTTF-100A

    MDR report key: 3433046 · Received October 21, 2013

    Report

    Report Number
    3009453079-2013-00028
    Event Type
    Other
    Date Received
    October 21, 2013
    Date of Event
    September 22, 2013
    Report Date
    September 23, 2013
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SERIAL NUMBERS: (B)(4). OTHER #: (B)(4). MFR DATE: 02/2013, 06/2013. PATIENT WITH RECURRENT GLIOBLASTOMA EXPERIENCED NEW ONSET SEIZURE RESULTING IN HOSPITAL ADMISSION WHILE ON NOVOTTF THERAPY. NOVOCURE MEDICAL OPINION IS THAT THE SEIZURE WAS RELATED TO UNDERLYING DIAGNOSIS OF PROGRESSIVE GLIOGLASTOMA, NOT RELATED TO NOVOTTF THERAPY. SEIZURE OCCURRED 4 MONTHS AFTER START OF NOVOTTF THERAPY. PATIENT CONTINUED WITH NOVOTTF AFTER A 2 WEEK HIATUS WITH NO FURTHER SEIZURE ACTIVITY REPORTED. SEIZURES WERE REPORTED AS ADVERSE EVENTS ON THE PIVOTAL PHASE III RECURRENT GBM TRIAL IN BOTH ARMS OF THE TRIAL (9% AND 4% IN NOVOTTF THERAPY AND CHEMOTHERAPY ARMS RESPECTIVELY). NONE OF THESE SEIZURES WERE CONSIDERED DEVICE OR CHEMOTHERAPY RELATED BY INVESTIGATORS. SEIZURES ARE A KNOWN COMPLICATION OF THE UNDERLYING DISEASE (RECURRENT GBM). ADDITIONAL RISK FACTORS FOR SEIZURE INCLUDE CONCOMITANT BEVACIZUMAB (SEIZURE WAS AMONG THE MOST COMMON BEVACIZUMAB-RELATED TOXICITIES IN PHASE II-III STUDIES, AFFECTING 9-9.7% OF PATIENTS. SOURCE: LAI ET AL., JCO, 2011, 29(2): 142-148/ CHINOT ET AL., NEURO-ONC, 2012., 14 (SUPPL 6): VI101-105).

    Description of Event or Problem · 1

    PATIENT WITH RECURRENT GLIOBLASTOMA BEGAN NOVOTTF THERAPY ON (B)(6) 2013. ON (B)(6) 2013, NOVOCURE WAS INFORMED THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO NEW ONSET SEIZURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED SLURRED SPEECH, STARING SPELLS, STIFFNESS OF EXTREMITIES AND LOSS OF CONSCIOUSNESS. PATIENT WAS TAKEN TO HOSPITAL VIA EMS, WAS ADMITTED AND STARTED ON LEVETIRACETAM AND DEXAMETHASONE. NOVOTTF THERAPY WAS TEMPORARILY DISCONTINUED. HEAD CT WAS QUESTIONABLE FOR BLEED. FOR THE NEXT WEEK, PATIENT WAS DESCRIBED AS BEING WEAK, SLOW AND MENTALLY "OFF." PATIENT WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2013, PATIENT WAS SEEN AT PRESCRIBING SITE AND NEUROLOGICAL EXAM WAS BACK TO BASELINE. PATIENT DENIED HEADACHES, NAUSEA, VOMITING, SEIZURE, IMBALANCE OR FALI. BRAIN MRI DID NOT SHOW EVIDENCE OF BLEED, EDEMA OR DISEASE PROGRESSION. DEXAMETHASONE DOSE WAS LOWERED WITH WEEKLY TAPER. NOVOTTF THERAPY WAS RESTARTED. LEVETIRACETAM WAS CONTINUED. NO FURTHER SEIZURES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538153 NOVOTTF-100A NZK NOVOCURE LTD TFH-9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization LISINOPRIL| ACETAMINOPHEN| BEVACIZUMAB| HYDROCODONE| CAFFINE| ASPIRIN| BUTALBITAL| METHYLPHENIDATE| OMEPRAZOLE| SIMVASTATIN| COMPAZINE| TRIMETHOPRIM| ALLOPURINOL| SULFAMETHOXAZOLE| ONDANSETRON