BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 4381095 · Received December 30, 2014

    Report

    Report Number
    3009453079-2014-00045
    Event Type
    Injury
    Date Received
    December 30, 2014
    Date of Event
    November 11, 2014
    Report Date
    December 2, 2014
    Manufacturer
    NOVOCURE LTD
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2013: PT WITH GLIOBLASTOMA EXPERIENCED NEW ONSET SEIZURE REQUIRING HOSPITALIZATION WHILE ON OPTUNE THERAPY. NOVOCURE AGREES WITH 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% AND 4% IN OPTUNE AND CHEMOTHERAPY ARMS RESPECTIVELY). NONE OF THESE SEIZURES WERE CONSIDERED DEVICE OF CHEMOTHERAPY RELATED BY INVESTIGATORS. SEIZURES ARE A KNOWN COMPLICATION OF THE UNDERLYING DISEASE (RECURRENT GBM). ADD'L RISK FACTORS FOR SEIZURE IN THIS PT INCLUDE CONCOMITANT THALIDOMIDE (CARRIES A WARNING TO CLOSELY MONITOR PTS WITH RISK FOR THE DEVELOPMENT OF SEIZURES CLOSELY FOR CLINICAL CHANGES THAT COULD PRECIPITATE ACUTE SEIZURE ACTIVITY. SOURCE: THALIDOMIDE PRESCRIBING INFO) AND CONCOMITANT TEMOZOLOMIDE ADVERSE REACTIONS IN PTS ON TEMOZOLOMIDE. SOURCE: TEMOZOLOMIDE PRESCRIBING INFO).

    Description of Event or Problem · 1

    PT WITH GLIOBLASTOMA (GBM) BEGAN OPTUNE TREATMENT ON (B)(6) 2014. ON (B)(6) 2014, NOVOCURE WAS INFORMED THAT THE PT HAD RECENTLY BEEN HOSPITALIZED DUE TO SEIZURE. PER HOSP SUMMARY, PT WAS HOSPITALIZED ON (B)(6) 2014 FOLLOWING ONSET SEIZURE. AT THE TIME OF THE EVENT, PT WAS IN THE PROCESS OF DOSE ESCALATION OF ANTI-SEIZURE PROPHYLAXIS (LEVETIRACETAM) TO THERAPEUTIC DOSE LEVEL. LEVETIRACETAM DOSE HAD RECENTLY BEEN INCREASED FROM 500 TO 1000 MG. DOSE WAS INCREASED TO 1500 MG AT HOSP. LEVETIRACETAM BLOOD VALUES WERE NOT MEASURED PRIOR TO OR AFTER THE EVENT. BRAIN CT SHOWED EVOLVING ENCEPHALOMALACIA IN THE AREA OF THE RIGHT FRONTAL TUMOR RESECTION. NO ACUTE HEMORRHAGE, MIDLINE SHIFT, HYDROCEPHALUS OR ACUTE ISCHEMIC CHANGES WERE IDENTIFIED. CHEST X-RAY SHOWED KNOWN PULMONARY VENOUS HYPERTENSION WITH NO FOCAL CONSOLIDATION, PNEUMOTHORAX OR PLEURAL EFFUSION. ON (B)(6) 2014, PT WAS DISCHARGED HOME IN IMPROVED CONDITION. PT CONTINUED WITH OPTUNE THERAPY WITH NO FURTHER SEIZURE ACTIVITY REPORTED. PER PHYSICIAN AT THE PRESCRIBING SITE, THE SEIZURE WAS RELATED TO UNDERLYING GBM AND WAS NOT RELATED TO OPTUNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858244 OPTUNE NZK NOVOCURE LTD TFH-9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization