Novocure's medical opinion is that based on the available information, the contribution of the optune gio device to the event cannot be ruled out.Fall is an expected event with device use (ef-11 4% and 8% ef-14 optune arm).Strangulation was not reported during ef-11 or ef-14 pivotal trials.Strangulation has been considered in the optune risk evaluation; initial risk was reduced as much as possible and residual risk is considered to be acceptable.The event did not result in permanent impairment of body function or permanent damage to a body structure.The event was considered temporary, the patient did recover from the event without reported sequelae.There are no long range health consequences to be expected.
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A 67-year-old male patient with glioblastoma (gbm) began optune gio therapy on(b)(6) 2023.On december 13, 2023, novocure received the reply regarding a patient survey conducted by an agency on behalf of novocure.In the survey, the patient reported the transducer array cords "choked" him which resulted in a fall that restricted his air supply.The patient was brought to the emergency room by ambulance.The date of event occurrence is unknown.No further details or causality assessment from the prescriber is available.
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