| Lot Number 1799212 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Death (1802); No Code Available (3191)
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| Event Date 08/15/2018 |
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Event Type
Death
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Event Description
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2 therasphere® vials were used to treat this patient, it cannot be determined which device contributed to the death of the patient.Refer to mfr# 3002124543-2018-00053 for another device associated with this event.Internal mcn: (b)(4).Subject number: (b)(6).Last sae report: 30 nov 2018.Sae: death.This report concerns subject (b)(6), a male subject born in (b)(6), who was enrolled in study (b)(6) entitled (b)(6).On (b)(6) 2017, the subject was randomized to the device arm.The subject received treatment with total 2 vials of therasphere®.The right hepatic lobe was treated with 1 vial on (b)(6) 2017, at a dose of 104.3 gy, vial size 6.5 gbq, with lot # 1799185.The second vial was administered in the left hepatic lobe on (b)(6) 2017, at a dose of 117.9 gy, vial size 8.0 gbq, with lot # 1799212.Treatment with study drug sorafenib was started on (b)(6) 2017 and on (b)(6) 2018, sorafenib was discontinued.The subject's relevant medical history and concomitant medications were not reported.On an unknown date in (b)(6) 2018, the subject died no other details were informed at the time of reporting this event.The subject discontinued participation in the study due to his death.The investigator assessed the event of death as grade 5 (fatal) in intensity, serious due to death of the subject.The event was assessed as possibly related to study device, to study procedure and to the standard of care therapy (sorafenib).The event is not related and to pre-existing condition.The event was considered as related to other specify unknown/ liver cirrhosis.The company agreed with the investigators assessment on grading the severity and seriousness criteria for the event of death.But the company assessed that since the mechanism of death and /or condition leading to death is currently unknown, the causality cannot be fully assessed.For now, seems to be related at least partially to pre-existing condition / disease under study.A supplemental report will be submitted if additional relevant information is received.
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Event Description
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This is a follow-up report to update subject weight, cause of death, study device hepatic segments treated, study treatment information, principal investigator's statement regarding causality and the company assessment.2 therasphere® vials were used to treat this patient, it cannot be determined which device contributed to the death of the patient.Refer to mfr# 3002124543-2018-00053 for another device associated with this event.Mfr # 3002124543-2018-00054.Internal mcn: (b)(4).Subject number: (b)(6).Last sae report: 08 jan 2019.Sae: death.On (b)(6) 2017, segment iv of the right hepatic lobe was treated with the study device therasphere®.On (b)(6) 2017, segments ii and iii were treated with the study device therasphere®.The investigator confirmed that the cause of death was unknown.Treatment with study drug sorafenib was started on (b)(6) 2017 with a dose of 200 mg, bid, and on (b)(6) 2018 sorafenib was discontinued due to unknown reasons.The investigator stated that while it was extremely unlikely that there was a relationship between the subject's death and the study device, procedure or sorafenib treatment, without accompanying information from the subject's care providers, he couldn't definitely rule anything at the time of the reporting.The company assessed that as the mechanism and cause of death is unknown (and no new data can be expected as site is unable to contact relevant person) the causality cannot be fully assessed.Death occurred 12-13 months after study treatment was discontinued therefore the most probable causality is pre-existing condition/disease under study.A supplemental report will be submitted if additional relevant information is received.
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Event Description
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This is a follow-up report to sae verbatim term, reasons for study treatment (sorafenib) discontinuation, company's assessment and more information from the site.2 therasphere® vials were used to treat this patient, it cannot be determined which device contributed to the death of the patient.Refer to mfr# 3002124543-2018-00053 for another device associated with this event.Mfr # 3002124543-2018-00054.Internal mcn: (b)(4).Subject number: (b)(6).Last sae report: 06 mar 2019.Sae: unknown cause of death.Study treatment (sorafenib) was discontinued due to aes: hepatotoxic side effects, increase transaminase, ldh (lactate dehydrogenase), symptoms of cephalgia, abdominal pain, nausea and a possible start of hand-foot-and-mouth disease.The site had also stated that they had no recent information that could help shed the light on the events leading to the patient's death, or indeed the cause of death.Therefore, while it was very unlikely that this death was related to the device/procedure/sorafenib, without a clear history of events leading to the patient's death they could not rule out anything with certainty.So far, they were unable to obtain a death notice, so they will continue to list the cause as unknown until they have more information.The site was also aware that other factors existed; however, given that they had no further information over the patient's medical history leading up to death they could not say conclusively or give an estimate as to how much such factors may have contributed to the patient's death.The site has sent an email to their cancer registry for further information, but there as there is no national death registry in germany this information is next to impossible to obtain.The company assessed the event as not related to study device, nor study procedure and nor study treatment.A supplemental report will be submitted if additional relevant information is received.
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Event Description
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This is a follow-up report to update the sae onset date from the site.2 therasphere® vials were used to treat this patient, it cannot be determined which device contributed to the death of the patient.Refer to mfr# 3002124543-2018-00053 for another device associated with this event.Mfr # 3002124543-2018-00054.Internal mcn: (b)(4).Subject number: (b)(6).Last sae report: 08 apr 2019.Sae: unknown cause of death.The site updated the onset date of the event of "unknown cause of death" as (b)(6) 2018, in this follow up report.A supplemental report will be submitted if additional relevant information is received.
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Event Description
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This is a follow-up report to update the sae event term, onset date, treatment medications, causality per reporter from the site.2 therasphere® vials were used to treat this subject, it cannot be determined which device contributed to the death of the subject.Refer to mfr# 3002124543-2018-00053 for another device associated with this event.Internal mcn: (b)(4).Subject number: (b)(6).Last sae report: (b)(6) 2019.Sae: gastrointestinal hemorrhage.On (b)(6) 2018, the subject was admitted to hospital with bloody vomiting.Hepatic encephalopathy was diagnosed.The event was diagnosed as gastrointestinal hemorrhage.The subject was treated with packed red blood cells (prbc's), vitamin k and 4 ppsb (prothrombin konzer treat) for gastrointestinal hemorrhage.For the hepatic encephalopathy, the subject received ornithine-aspartate (hepa-merz) and lactulose (biliteral).Endoscopy and colonoscopy were planned for the subject, but the subject died before these diagnostic procedures were planned to be performed.It was reported that, although the event was unlikely related to the study device or procedure, the radioembolization from cirt could have had a worsening effect on the pre-existing liver cirrhosis of the subject.No additional information is expected at this time.
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Search Alerts/Recalls
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