The events were reported through a retrospective clinical trial.The events are considered serious due to hospitalization and related to therasphere administration.Btg medical assessment: subject (b)(6) is a (b)(6) male patient enrolled on the (b)(6) study.Diagnosed with hcc on an unknown date.Presence of portal hypertension with oesophagus varices and pancytopenia at the blood test.Etiologic associations: liver cirrhosis; (b)(6); previous alcohol addiction; no prior sorafenib treatment before therasphere treatment; bclc stage: c; no disease specific surgery.Unknown date patient received therasphere treatment (around (b)(6) 2016).Cp at base line at least (b)(6), the patient had 3 points on albumin.No concomitant disease.On (b)(6) 2016 the patient experienced: edema; reduced general condition; ascites; albumin decreased; bilirubin increased; creatinine increased; liver decompensation.Reild events: edema; ascites; albumin deceased; bilirubin increased; liver decompensation: serious adverse events, related to therasphere.Expected reduced general condition: serious adverse event, related to therasphere.Expected creatinine increased: non-serious adverse event, not related to therasphere.Expected.All events are anticipated adverse events listed in the risk management documentation/ifu.Therasphere is contra-indicated for patients with severe liver dysfunction and physicians should consider when selecting patients (patient was child (b)(6) at entry).No device malfunction was reported and no corrective and preventive action (capa) plan has been identified.The lot number associated with the therasphere administration was not reported, therefore no investigation could be performed.Additional information has also been sought regarding the treatment date and hospital admission and discharge dates if additional information becomes available, a follow up report will be submitted.No other information is available that could confirm/deny the alleged event.At this time this report is considered final.
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