BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 4417624 · Received January 13, 2015

    Report

    Report Number
    3009453079-2015-00046
    Event Type
    Injury
    Date Received
    January 13, 2015
    Date of Event
    December 13, 2014
    Report Date
    December 13, 2014
    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

    PT WITH GLIOBLASTOMA EXPERIENCED NEW ONSET SEIZURE REQUIRING HOSPITALIZATION WHILE ON OPTUNE THERAPY. NOVOCURE AGREES WITH THE PRESCRIBING SITE PHYSICIAN THAT THE SEIZURE WAS RELATED TO UNDERLYING GBM. SEIZURE WAS NOT RELATED TO OPTUNE. PT CONTINUED WITH OPTUNE 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 PERCENT AND 4 PERCENT IN OPTUNE 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 IN THIS PT INCLUDE CONCOMITANT BEVACIZUMAB [SEIZURE WAS AMONG THE MOSE COMMON BEVACIZUMAB-RELATED TOXICITIES IN PHASE II-III STUDIES, AFFECTING 9-9.7 PERCENT 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 TEMOZOLOMIDE [CONVULSIONS ARE AMONG THE MOST COMMONLY REPORTED ADVERSE REACTIONS IN PTS ON TEMOZOLOMIDE. SOURCE: TEMOZOLOMIDE PRESCRIBING INFORMATION].

    Description of Event or Problem · 1

    PT WITH RECURRENT GLIOBLASTOMA (GMB) BEGAN OPTUNE TREATMENT ON (B)(6) 2014. ON (B)(6) 2014, NOVOCURE WAS INFORMED THAT THE PT HAD VISITED THE EMERGENCY ROOM AFTER EXPERIENCING A NEW ONSET SEIZURE. PER THE PRESCRIBING PHYSICIAN, THE PT DID NOT HAVE A HISTORY OF SEIZURE AND WAS NOT ON ANTI-SEIZURE PROPHYLAXIS PRIOR TO THE EVENT. PT WAS ADMITTED TO THE HOSPITAL AND TREATED WITH UNSPECIFIED ANTI-EPILEPTICS. IMAGING RESULTS WERE NOT PROVIDED. OPTUNE THERAPY WAS CONTINUED. PER THE PRESCRIBER, THE EVENT WAS RELATED TO UNDERLYING GBM PROGRESSION AND INVOLVEMENT OF THE TEMPORAL LOBE. THE EVENT WAS NOT RELATED TO OPTUNE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29746 OPTUNE NZK NOVOCURE LTD TFH-9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization POLYETHYLENE GLYCOL| DOCUSATE SODIUM| ACETAMINOPHEN| LORAZEPAM| TRIMETHOPRIM/SULFAMETHOXAZOLE| ETOPOSIDE| BEVACIZUMAB| ONDANSETRON| CARBOPLATIN