BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOTTF-100A

    MDR report key: 3608618 · Received November 22, 2013

    Report

    Report Number
    3009453079-2013-00033
    Event Type
    Other
    Date Received
    November 22, 2013
    Date of Event
    October 26, 2013
    Report Date
    October 26, 2013
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L SERIAL NUMBER - (B)(4). (B)(4). ADD'L DEVICE MANUFACTURE DATE: 10/2013. PT WITH RECURRENT GLIOBLASTOMA EXPERIENCED NEW ONSET SEIZURE RESULTING IN HOSP ADMISSION WHILE ON NOVOTTF THERAPY. NOVOCURE AGREES WITH PRESCRIBING MD THAT SEIZURES WERE RELATED TO UNDERLYING GBM AND POSSIBLE PROGRESSIVE DISEASE. SEIZURES WERE NOT RELATED TO NOVOTTF THERAPY. PT CONTINUED WITH NOVOTTF THERAPY 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% 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). ADD'L 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 PTS. SOURCE: LAI ET AL., JCO, 2011, 29(2): 142-148 / CHINOT ET AL., NEURO-ONC, 2012, 14 (SUPPL 6): VI101-105] AND CONCOMITANT METHYLPHENIDATE [CARRIES A WARNING FOR SEIZURES DUE TO CLINICAL EVIDENCE OF STIMULANTS LOWERING THE SEIZURE THRESHOLD IN PTS WITH NO HISTORY OF SEIZURE. SOURCE: METHYLPHENIDATE PRESCRIBING INFO].

    Description of Event or Problem · 1

    PT WITH RECURRENT GLIOBLASTOMA BEGAN NOVOTTF THERAPY ON (B)(6) 2013. ON (B)(6) 2013, NOVOCURE WAS INFORMED THAT THE PT HAD BEEN HOSPITALIZED DUE TO NEW ONSET GENERALIZED SEIZURE. PT HAD BEEN ON ANTI-SEIZURE PROPHYLAXIS (LEVETIRACETAM) BUT HAD DISCONTINUED SEVERAL MONTHS PRIOR TO THE EVENT (NO FURTHER INFO AVAILABLE). PT WAS TREATED WITH LEVETIRACETAM AND STEROIDS. PER THE PRESCRIBING MD, SEIZURES WERE DUE TO UNDERLYING GBM AND POSSIBLE DISEASE PROGRESSION, NOT RELATED TO NOVOTTF THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610328 NOVOTTF-100A NZK NOVOCURE LTD TFH-9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization LOMUSTINE (CCNU)| ONDANSETRON| DEXAMETHASONE| METHYLPHENIDATE| BEVACIZUMAB| DIAZEPAM| PROCHLORPERAZINE| CITALOPRAM