BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 5630509 · Received May 4, 2016

    Report

    Report Number
    3009453079-2016-00070
    Event Type
    Injury
    Date Received
    May 4, 2016
    Date of Event
    February 27, 2016
    Report Date
    May 3, 2016
    Manufacturer
    NOVOCURE LTD.
    Product Code
    NZK
    UDI-DI
    07290107980401
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA EXPERIENCED NEW ONSET SEIZURE RESULTING IN HOSPITAL ADMISSION WHILE ON OPTUNE THERAPY. NOVOCURE MEDICAL OPINION IS THAT THE SEIZURE WAS RELATED TO THE UNDERLYING DIAGNOSIS OF GLIOBLASTOMA, AND WAS NOT RELATED TO OPTUNE. SEIZURE OCCURRED APPROXIMATELY 1 MONTH AFTER THE START OF OPTUNE THERAPY. PATIENT CONTINUED WITH OPTUNE THERAPY AFTER A 5 DAY TREATMENT HIATUS WITH NO FURTHER SEIZURE ACTIVITY REPORTED. SEIZURES WERE REPORTED AS ADVERSE EVENTS 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 (16% AND 18% IN OPTUNE/TMZ AND TMZ ARMS RESPECTIVELY). NONE OF THESE SEIZURES WERE CONSIDERED DEVICE OR CHEMOTHERAPY RELATED BY INVESTIGATORS. SEIZURES ARE A KNOWN COMPLICATION OF THE UNDERLYING DISEASE (GBM). ADDITIONAL RISK FACTORS FOR SEIZURE IN THIS PATIENT 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): 1420148 / CHINOT ET AL., NEURO-ONC, 2012, 14 (SUPPL 6): VI101-105], CONCOMITANT TEMOZOLOMIDE [CONVULSIONS ARE LISTED AS AMONG THE MOST COMMON ADVERSE REACTIONS. SOURCE: TEMOZOLOMIDE PRESCRIBING INFORMATION] AND CONCOMITANT DEXAMETHASONE [CONVULSION IS LISTED AS A KNOWN ADVERSE REACTION. SOURCE: DEXAMETHASONE PRESCRIBING INFORMATION].

    Description of Event or Problem · 1

    PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2016. ON (B)(6) 2016 NOVOCURE WAS INFORMED THAT THE PATIENT HAD BEEN HOSPITALIZED (B)(6) 2016 DUE TO A NEW ONSET SEIZURE. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED DURING THIS TIME PERIOD. ON (B)(6) 2016 THE PRESCRIBING PHYSICIAN CONFIRMED THAT THE PATIENT HAD PRESENTED WITH TUMOR PROGRESSION AND WAS NOT ON ANTICONVULSANTS AT THE TIME OF THE SEIZURE. NO ADDITIONAL INFORMATION WAS PROVIDED. PHYSICIAN STATED THAT THE SEIZURE WAS PROBABLY RELATED TO UNDERLYING DISEASE, HOWEVER A RELATIONSHIP WITH OPTUNE THERAPY COULD NOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286426 OPTUNE OPTUNE NZK NOVOCURE LTD. TFH-9000 N/A 07290107980401

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization TEMOZOLOMIDE