SIR-SPHERES® Y-90 RESIN MICROSPHERES
Report
- Report Number
- 3005579300-2019-00001
- Event Type
- Injury
- Date Received
- March 15, 2019
- Date of Event
- March 1, 2019
- Report Date
- October 9, 2019
- Manufacturer
- SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED
- Product Code
- NAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
SENDER'S COMMENTS: THE ADVERSE EVENT OF POST EMBOLIZATION SYNDROME WAS CLASSIFIED AS SERIOUS DUE TO HOSPITALIZATION OF A 78-YEAR OLD FEMALE PATIENT ABOUT 9 DAYS AFTER MAPPING PROCEDURE AND ONE DAY AFTER IMPLANTATION OF SIR-SPHERES. THE PATIENT HAD NOT YET RECEIVED CHEMOTHERAPY TREATMENT. SINCE THE EVENT WAS OF SEVERE SEVERITY AND ONLY MILD TO MODERATE POST EMBOLIZATION SYNDROME IS EXPECTED, THE EVENT IS UNEXPECTED FOR SIR-SPHERES MICROSPHERES, RELATED PROCEDURES AND CHEMOTHERAPY. THE TEMPORAL RELATIONSHIP IS IMPLAUSIBLE FOR CHEMOTHERAPY AND MAPPING PROCEDURE AND PLAUSIBLE FOR SIR-SPHERES MICROSPHERES AND IMPLANT PROCEDURE. POST EMBOLIZATION SYNDROME, WHICH MANIFESTED WITH SEVERE ABDOMINAL PAIN IN THIS PATIENT, CAN OCCUR AS A RESULT OF THE RADIATION INJURY AND THE EMBOLIC EFFECT OF THE SIR-SPHERES MICROSPHERES ON THE TUMOUR VASCULATURE. THE PATIENT'S UNDERLYING MALIGNANT DISEASE AND HER CONCOMITANT MEDICATION INCLUDING HYDROXYZINE AND MORPHINE CAN ALSO PROMOTE ABDOMINAL PAIN. THE INVESTIGATOR ASSESSED THE EVENT AS DEFINITELY RELATED TO SIR-SPHERES MICROSPHERES AND DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE MAPPING AND IMPLANT PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS PROBABLY RELATED TO SIR-SPHERES MICROSPHERES AND IMPLANTATION PROCEDURE CONSIDERING THE PLAUSIBLE TEMPORAL COURSE AND THAT ABDOMINAL PAIN CAN OCCUR IN ASSOCIATION WITH THE IMPLANTATION PROCEDURE. FOR THE MAPPING PROCEDURE THE CAUSALITY IS ASSESSED AS UNLIKELY AND FOR CHEMOTHERAPY THE CAUSALITY IS ASSESSED AS NOT RELATED. WITH FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2019 IT WAS CLARIFIED THAT THE SERIOUSNESS CRITERION IS THE PROLONGATION OF THE HOSPITALIZATION, WHICH WAS INITIALLY REQUIRED FOR THE IMPLANTATION PROCEDURE AND THEN PROLONGED DUE TO OCCURRENCE OF THE EVENT. IN ADDITION, THE INVESTIGATOR SPECIFIED HIS CAUSALITY ASSESSMENT AS NOT RELATED TO CHEMOTHERAPY AND MAPPING PROCEDURE AND AS DEFINITELY RELATED TO IMPLANTATION PROCEDURE AND SIR-SPHERES MICROSPHERES. THE SPONSOR'S INITIAL CAUSALITY ASSESSMENT REMAINS UNCHANGED. WITH FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2019 THE INVESTIGATOR'S CAUSALITY ASSESSMENT CHANGED FROM DEFINITELY RELATED TO IMPLANT PROCEDURE TO NOT RELATED TO IMPLANT PROCEDURE. OVERALL, THE INVESTIGATOR ASSESSED THE EVENT AS DEFINITELY RELATED TO SIR-SPHERES MICROSPHERES (DEVICE) AND AS NOT RELATED TO MAPPING AND IMPLANT PROCEDURE AND AS NOT RELATED TO CHEMOTHERAPY. SINCE POST EMBOLISATION SYNDROME IN PARTICULAR BELONGS TO THE CHARACTERISTIC PRODUCT RELATED RISKS, THE SPONSOR CONCURS AND ASSESSES THE EVENT AS PROBABLY RELATED TO SIR-SPHERES MICROSPHERES (DEVICE) AND AS NOT RELATED TO MAPPING AND IMPLANT PROCEDURE AND NOT RELATED TO CHEMOTHERAPY.
SENDER'S COMMENTS: THE ADVERSE EVENT OF POST EMBOLIZATION SYNDROME WAS CLASSIFIED AS SERIOUS DUE TO HOSPITALIZATION OF A 78-YEAR OLD FEMALE PATIENT ABOUT 9 DAYS AFTER MAPPING PROCEDURE AND ONE DAY AFTER IMPLANTATION OF SIR-SPHERES. THE PATIENT HAD NOT YET RECEIVED CHEMOTHERAPY TREATMENT. SINCE THE EVENT WAS OF SEVERE SEVERITY AND ONLY MILD TO MODERATE POST EMBOLIZATION SYNDROME IS EXPECTED, THE EVENT IS UNEXPECTED FOR SIR-SPHERES MICROSPHERES, RELATED PROCEDURES AND CHEMOTHERAPY. THE TEMPORAL RELATIONSHIP IS IMPLAUSIBLE FOR CHEMOTHERAPY AND MAPPING PROCEDURE AND PLAUSIBLE FOR SIR-SPHERES MICROSPHERES AND IMPLANT PROCEDURE. POST EMBOLIZATION SYNDROME, WHICH MANIFESTED WITH SEVERE ABDOMINAL PAIN IN THIS PATIENT, CAN OCCUR AS A RESULT OF THE RADIATION INJURY AND THE EMBOLIC EFFECT OF THE SIR-SPHERES MICROSPHERES ON THE TUMOUR VASCULATURE. THE PATIENT'S UNDERLYING MALIGNANT DISEASE AND HER CONCOMITANT MEDICATION INCLUDING HYDROXYZINE AND MORPHINE CAN ALSO PROMOTE ABDOMINAL PAIN. THE INVESTIGATOR ASSESSED THE EVENT AS DEFINITELY RELATED TO SIR-SPHERES MICROSPHERES AND DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE MAPPING AND IMPLANT PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS PROBABLY RELATED TO SIR-SPHERES MICROSPHERES AND IMPLANTATION PROCEDURE CONSIDERING THE PLAUSIBLE TEMPORAL COURSE AND THAT ABDOMINAL PAIN CAN OCCUR IN ASSOCIATION WITH THE IMPLANTATION PROCEDURE. FOR THE MAPPING PROCEDURE THE CAUSALITY IS ASSESSED AS UNLIKELY AND FOR CHEMOTHERAPY THE CAUSALITY IS ASSESSED AS NOT RELATED. WITH FOLLOW-UP INFORMATION RECEIVED ON 20-MAR-2019 IT WAS CLARIFIED THAT THE SERIOUSNESS CRITERION IS THE PROLONGATION OF THE HOSPITALIZATION, WHICH WAS INITIALLY REQUIRED FOR THE IMPLANTATION PROCEDURE AND THEN PROLONGED DUE TO OCCURRENCE OF THE EVENT. IN ADDITION, THE INVESTIGATOR SPECIFIED HIS CAUSALITY ASSESSMENT AS NOT RELATED TO CHEMOTHERAPY AND MAPPING PROCEDURE AND AS DEFINITELY RELATED TO IMPLANTATION PROCEDURE AND SIR-SPHERES MICROSPHERES. THE SPONSOR'S INITIAL CAUSALITY ASSESSMENT REMAINS UNCHANGED.
A SERIOUS ADVERSE EVENT REPORT, (CASE NUMBER (B)(4)), WAS RECEIVED FROM AN INVESTIGATOR IN FRANCE REGARDING A FEMALE PATIENT (PATIENT NO. (B)(6)) ENROLLED IN "A PROSPECTIVE, MULTICENTRE, RANDOMISED, CONTROLLED STUDY EVALUATING SIR-SPHERES® Y-90 RESIN MICROSPHERES PRECEDING STANDARD CISPLATIN-GEMCITABINE (CIS-GEM) CHEMOTHERAPY VERSUS CIS-GEM CHEMOTHERAPY ALONE AS FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA (SIRCCA)", STUDY CODE (B)(4). INITIAL REPORT WAS RECEIVED ON (B)(6) 2019. THE REPORTED EVENT TERM WAS POST-EMBOLISATION SYNDROME. AT THE TIME OF THE EVENT ONSET THE PATIENT WAS 78-YEAR-OLD. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA. THE PATIENT RECEIVED A COMBINED TREATMENT MODALITY OF (SIR-SPHERES MICROSPHERES + CIS-GEM CHEMOTHERAPY). MAPPING PROCEDURE WAS PERFORMED ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT WAS HOSPITALIZED, IMPLANTATION OF SIR-SPHERES MICROSPHERES WAS PERFORMED ON (B)(6) 2019. AT THE TIME OF THE EVENT TREATMENT WITH CHEMOTHERAPY AGENTS (CISPLATIN-GEMCITABINE) WAS NOT STARTED. ON (B)(6) 2019, THE PATIENT PRESENTED WITH SEVERE ABDOMINAL PAIN BUT NO FEVER AND WAS DIAGNOSED WITH POST-EMBOLISATION SYNDROME. THE EVENT WAS SEVERE. A CT-SCAN DID NOT SHOW ANY PROCEDURE COMPLICATION. CONCOMITANT MEDICATION INCLUDED ATARAX (HYDROXYZINE) 25 MG, ONCE, ORAL, ON (B)(6) 2019; LIDOCAINE/PRILOCAINE AGUETTANT (LIDOCAINE, PRILOCAINE) 5%, ONCE, CUTANEOUS, ON (B)(6) 2019; DOLIPRANE (PARACETAMOL) 500 MG, 2-6 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019 TO (B)(6) 2019; ALPRAZOLAM ARROW (ALPRAZOLAM) 0.25 MG, 1-4 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019 TO (B)(6) 2019; ACTISKENAN (MORPHINE SULFATE) 5 MG, 5 TO 50 MG DAILY AS NEEDED, ORAL, FROM (B)(6) 2019 TO (B)(6) 2019 AND 5 TO 30 MG DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019 TO (B)(6) 2019; PRIMPERAN (METOCLOPRAMIDE) 10 MG/2ML, 1-3 AMPULES DAILY, I.V., AS NEEDED, FROM (B)(6) 2019 TO (B)(6) 2019; ONDANSETRON ACCORD (ONDANSETRON) 2MG/2ML, 1-3 AMPULES DAILY, I.V., AS NEEDED, FROM (B)(6) 2019 TO (B)(6) 2019; PARACETAMOL KABI (PARACETAMOL)10 MG/ML, 1 TO 3 G DAILY, I.V., AS NEEDED, FROM (B)(6) 2019 TO (B)(6) 2019; MORPHINE (CHLORHYDRATE) AGUETTANT (MORPHINE CHLORHYDRATE) 10 MG/ML, 2-20 MG DAILY, I.V., AS NEEDED, FROM (B)(6) 2019 TO (B)(6) 2019; CONTRAMAL (TRAMADOL) 50 MG, 1 TO 3 CAPSULES DAILY, ORAL, AS NEEDED, ON (B)(6) 2019 AND (B)(6) 2019; PRIMPERAN (METOCLOPRAMIDE) 10 MG, 1 TO 3 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019 TO (B)(6) 2019; LOVENOX (ENOXAPARIN NATRIUM) 4000 UI (40MG)/0.4 ML, 1 SYRINGE DAILY, S.C., FROM (B)(6) 2019 TO (B)(6) 2019; SPASFON LYOC (PHLOROGLUCINOL) 80 MG, 1-3 LYOPHYILISATES DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019 TO (B)(6)2019; GLUCIDION G5 (GLUCOSE, NACL, KCL) 1000 ML/24H, ONCE, I.V., ON (B)(6) 2019 AND POLYIONIQUE GLUCOSE 5% (GLUCOSE, NACL, KCL) 1000ML/24 H, ONCE DAILY, I.V., ON (B)(6) 2019 AND (B)(6) 2019. THE PATIENT RECOVERED AND WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2019. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2019: FURTHER CONCOMITANT MEDICATION INCLUDED TRANSILANE (PSYLLIUM HUSK), WHEREAS PRIMPERAN, PARACETAMOL, ONDANSETRON AND MORPHINE WERE CLASSIFIED BY INVESTIGATOR AS TREATMENT DRUGS. THE INVESTIGATOR CLARIFIED, THAT THE PATIENT HAD ALREADY BEEN HOSPITALIZED ON (B)(6) 2019 FOR IMPLANTATION OF SIR-SPHERES MICROSPHERES ON (B)(6) 2019, WHEN THE EVENT OF POST EMBOLIZATION SYNDROME LED TO PROLONGATION OF HOSPITALIZATION. FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(6) 2019. IMPLANTED ACTIVITY OF SIR-SPHERES MICROSPHERES WAS REPORTED AS 0.82 GBQ. REPORTER'S COMMENTS: THE INVESTIGATOR ASSESSED THE EVENT AS DEFINITELY RELATED TO SIR-SPHERES MICROSPHERES (MEDIAL DEVICE). NO CAUSALITY ASSESSMENT FOR SIR-SPHERES MICROSPHERES MAPPING AND IMPLANT PROCEDURE, CISPLATIN AND GEMCITABINE WAS PROVIDED. WITH FOLLOW-UP INFORMATION ON (B)(6) 2019 THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO CISPLATIN AND GEMCITABINE, AS NOT RELATED TO THE SIR-SPHERES MICROSPHERES (MAPPING PROCEDURE), BUT AS DEFINITELY RELATED TO THE SIR-SPHERES MICROSPHERES (IMPLANT PROCEDURE). THIS REPORT HAS ALSO BEEN SUBMITTED AS AN IDE REPORT FOR #(B)(4). WITH FOLLOW-UP INFORMATION RECEIVED ON 13-SEP-2019 THE INVESTIGATOR CHANGED THE CAUSAL RELATIONSHIP TO SIR-SPHERES MICROSPHERES (IMPLANT PROCEDURE) TO NOT RELATED.
A SERIOUS ADVERSE EVENT REPORT, (CASE NUMBER (B)(4)), WAS RECEIVED FROM AN INVESTIGATOR IN FRANCE REGARDING A FEMALE PATIENT (PATIENT NO. (B)(6) ) ENROLLED IN "A PROSPECTIVE, MULTICENTRE, RANDOMISED, CONTROLLED STUDY EVALUATING SIR-SPHERES® Y-90 RESIN MICROSPHERES PRECEDING STANDARD CISPLATIN-GEMCITABINE (CIS-GEM) CHEMOTHERAPY VERSUS CIS-GEM CHEMOTHERAPY ALONE AS FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA (SIRCCA)", STUDY CODE STX0115. INITIAL REPORT WAS RECEIVED ON 05-MAR-2019. THE REPORTED EVENT TERM WAS POST-EMBOLISATION SYNDROME. AT THE TIME OF THE EVENT ONSET THE PATIENT WAS 78-YEAR-OLD. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA. THE PATIENT RECEIVED A COMBINED TREATMENT MODALITY OF (SIR-SPHERES MICROSPHERES + CIS-GEM CHEMOTHERAPY). MAPPING PROCEDURE WAS PERFORMED ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT WAS HOSPITALIZED, IMPLANTATION OF SIR-SPHERES MICROSPHERES WAS PERFORMED ON (B)(6) 2019. AT THE TIME OF THE EVENT TREATMENT WITH CHEMOTHERAPY AGENTS (CISPLATIN-GEMCITABINE) WAS NOT STARTED. ON (B)(6) 2019, THE PATIENT PRESENTED WITH SEVERE ABDOMINAL PAIN BUT NO FEVER AND WAS DIAGNOSED WITH POST-EMBOLISATION SYNDROME. THE EVENT WAS SEVERE. A CT-SCAN DID NOT SHOW ANY PROCEDURE COMPLICATION. CONCOMITANT MEDICATION INCLUDED ATARAX (HYDROXYZINE) 25 MG, ONCE, ORAL, ON (B)(6) 2019; LIDOCAINE/PRILOCAINE AGUETTANT (LIDOCAINE, PRILOCAINE) 5%, ONCE, CUTANEOUS, ON (B)(6) 2019; DOLIPRANE (PARACETAMOL) 500 MG, 2-6 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; ALPRAZOLAM ARROW (ALPRAZOLAM) 0.25 MG, 1-4 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; ACTISKENAN (MORPHINE SULFATE) 5 MG, 5 TO 50 MG DAILY AS NEEDED, ORAL, FROM (B)(6) 2019 AND 5 TO 30 MG DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; PRIMPERAN (METOCLOPRAMIDE) 10 MG/2ML, 1-3 AMPULES DAILY, I.V., AS NEEDED, FROM (B)(6) 2019; ONDANSETRON ACCORD (ONDANSETRON) 2MG/2ML, 1-3 AMPULES DAILY, I.V., AS NEEDED, FROM (B)(6) 2019; PARACETAMOL KABI (PARACETAMOL)10 MG/ML, 1 TO 3 G DAILY, I.V., AS NEEDED, FROM (B)(6) 2019; MORPHINE (CHLORHYDRATE) AGUETTANT (MORPHINE CHLORHYDRATE) 10 MG/ML, 2-20 MG DAILY, I.V., AS NEEDED, FROM (B)(6) 2019; CONTRAMAL (TRAMADOL) 50 MG, 1 TO 3 CAPSULES DAILY, ORAL, AS NEEDED, ON (B)(6) 2019; PRIMPERAN (METOCLOPRAMIDE) 10 MG, 1 TO 3 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; LOVENOX (ENOXAPARIN NATRIUM) 4000 UI (40MG)/0.4 ML, 1 SYRINGE DAILY, S.C., FROM (B)(6) 2019; SPASFON LYOC (PHLOROGLUCINOL) 80 MG, 1-3 LYOPHYILISATES DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; GLUCIDION G5 (GLUCOSE, NACL, KCL) 1000 ML/24H, ONCE, I.V., ON (B)(6) 2019 AND POLYIONIQUE GLUCOSE 5% (GLUCOSE, NACL, KCL) 1000ML/24 H, ONCE DAILY, I.V., ON (B)(6) 2019 AND (B)(6) 2019. THE PATIENT RECOVERED AND WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2019. FOLLOW-UP INFORMATION WAS RECEIVED ON 20-MAR-2019: FURTHER CONCOMITANT MEDICATION INCLUDED TRANSILANE (PSYLLIUM HUSK), WHEREAS PRIMPERAN, PARACETAMOL, ONDANSETRON AND MORPHINE WERE CLASSIFIED BY INVESTIGATOR AS TREATMENT DRUGS. THE INVESTIGATOR CLARIFIED, THAT THE PATIENT HAD ALREADY BEEN HOSPITALIZED ON (B)(6) 2019 FOR IMPLANTATION OF SIR-SPHERES MICROSPHERES ON (B)(6) 2019, WHEN THE EVENT OF POST EMBOLIZATION SYNDROME LED TO PROLONGATION OF HOSPITALIZATION. REPORTER'S COMMENTS: THE INVESTIGATOR ASSESSED THE EVENT AS DEFINITELY RELATED TO SIR-SPHERES MICROSPHERES (MEDIAL DEVICE). NO CAUSALITY ASSESSMENT FOR SIR-SPHERES MICROSPHERES MAPPING AND IMPLANT PROCEDURE, CISPLATIN AND GEMCITABINE WAS PROVIDED. WITH FOLLOW-UP INFORMATION ON 20-MAR-2019 THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO CISPLATIN AND GEMCITABINE, AS NOT RELATED TO THE SIR-SPHERES MICROSPHERES (MAPPING PROCEDURE), BUT AS DEFINITELY RELATED TO THE SIR-SPHERES MICROSPHERES (IMPLANT PROCEDURE). THIS REPORT HAS ALSO BEEN SUBMITTED AS AN IDE REPORT FOR #(B)(4).
SENDER'S COMMENTS: THE ADVERSE EVENT OF POST EMBOLIZATION SYNDROME WAS CLASSIFIED AS SERIOUS DUE TO HOSPITALIZATION OF A (B)(6)-YEAR OLD FEMALE PATIENT ABOUT 9 DAYS AFTER MAPPING PROCEDURE AND ONE DAY AFTER IMPLANTATION OF SIR-SPHERES. THE PATIENT HAD NOT YET RECEIVED CHEMOTHERAPY TREATMENT. SINCE THE EVENT WAS OF SEVERE SEVERITY AND ONLY MILD TO MODERATE POST EMBOLIZATION SYNDROME IS EXPECTED, THE EVENT IS UNEXPECTED FOR SIR-SPHERES MICROSPHERES, RELATED PROCEDURES AND CHEMOTHERAPY. THE TEMPORAL RELATIONSHIP IS IMPLAUSIBLE FOR CHEMOTHERAPY AND MAPPING PROCEDURE AND PLAUSIBLE FOR SIR-SPHERES MICROSPHERES AND IMPLANT PROCEDURE. POST EMBOLIZATION SYNDROME, WHICH MANIFESTED WITH SEVERE ABDOMINAL PAIN IN THIS PATIENT, CAN OCCUR AS A RESULT OF THE RADIATION INJURY AND THE EMBOLIC EFFECT OF THE SIR-SPHERES MICROSPHERES ON THE TUMOUR VASCULATURE. THE PATIENT'S UNDERLYING MALIGNANT DISEASE AND HER CONCOMITANT MEDICATION INCLUDING HYDROXYZINE AND MORPHINE CAN ALSO PROMOTE ABDOMINAL PAIN. THE INVESTIGATOR ASSESSED THE EVENT AS DEFINITELY RELATED TO SIR-SPHERES MICROSPHERES AND DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE MAPPING AND IMPLANT PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS PROBABLY RELATED TO SIR-SPHERES MICROSPHERES AND IMPLANTATION PROCEDURE CONSIDERING THE PLAUSIBLE TEMPORAL COURSE AND THAT ABDOMINAL PAIN CAN OCCUR IN ASSOCIATION WITH THE IMPLANTATION PROCEDURE. FOR THE MAPPING PROCEDURE THE CAUSALITY IS ASSESSED AS UNLIKELY AND FOR CHEMOTHERAPY THE CAUSALITY IS ASSESSED AS NOT RELATED.
A SERIOUS ADVERSE EVENT REPORT, (CASE NUMBER (B)(4)), WAS RECEIVED FROM AN INVESTIGATOR IN (B)(6) REGARDING A FEMALE PATIENT (PATIENT NO. (B)(6)) ENROLLED IN "A (B)(6) STUDY EVALUATING SIR-SPHERES® Y-90 RESIN MICROSPHERES PRECEDING STANDARD CISPLATIN-GEMCITABINE (CIS-GEM) CHEMOTHERAPY VERSUS CIS-GEM CHEMOTHERAPY ALONE AS FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA (SIRCCA)", STUDY CODE (B)(6). INITIAL REPORT WAS RECEIVED ON 05-MAR-2019. THE REPORTED EVENT TERM WAS POST-EMBOLISATION SYNDROME. AT THE TIME OF THE EVENT ONSET, THE PATIENT WAS (B)(6) YEAR-OLD. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR UNRESECTABLE INTRAHEPATIC CHOLANGIOCARCINOMA. THE PATIENT RECEIVED A COMBINED TREATMENT MODALITY OF (SIR-SPHERES MICROSPHERES + CIS-GEM CHEMOTHERAPY). MAPPING PROCEDURE WAS PERFORMED ON (B)(6) 2019. ON (B)(6) 2019 THE PATIENT WAS HOSPITALIZED, IMPLANTATION OF SIR-SPHERES MICROSPHERES WAS PERFORMED ON (B)(6) 2019. AT THE TIME OF THE EVENT TREATMENT WITH CHEMOTHERAPY AGENTS (CISPLATIN-GEMCITABINE) WAS NOT STARTED. ON (B)(6) 2019, THE PATIENT PRESENTED WITH SEVERE ABDOMINAL PAIN BUT NO FEVER AND WAS DIAGNOSED WITH POST-EMBOLISATION SYNDROME. THE EVENT WAS SEVERE. A CT-SCAN DID NOT SHOW ANY PROCEDURE COMPLICATION. CONCOMITANT MEDICATION INCLUDED ATARAX (HYDROXYZINE) 25 MG, ONCE, ORAL, ON (B)(6) 2019; LIDOCAINE/PRILOCAINE AGUETTANT (LIDOCAINE, PRILOCAINE) 5%, ONCE, CUTANEOUS, ON (B)(6) 2019; DOLIPRANE (PARACETAMOL) 500 MG, 2-6 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; ALPRAZOLAM ARROW (ALPRAZOLAM) 0.25 MG, 1-4 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; ACTISKENAN (MORPHINE SULFATE) 5 MG, 5 TO 50 MG DAILY AS NEEDED, ORAL, FROM (B)(6) 2019 AND 5 TO 30 MG DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; PRIMPERAN (METOCLOPRAMIDE) 10 MG/2ML, 1-3 AMPULES DAILY, I.V., AS NEEDED, FROM (B)(6) 2019; ONDANSETRON ACCORD (ONDANSETRON) 2MG/2ML, 1-3 AMPULES DAILY, I.V., AS NEEDED, FROM (B)(6) 2019; PARACETAMOL KABI (PARACETAMOL)10 MG/ML, 1 TO 3 G DAILY, I.V., AS NEEDED, FROM (B)(6) 2019; MORPHINE (CHLORHYDRATE) AGUETTANT (MORPHINE CHLORHYDRATE) 10 MG/ML, 2-20 MG DAILY, I.V., AS NEEDED, FROM (B)(6) 2019; CONTRAMAL (TRAMADOL) 50 MG, 1 TO 3 CAPSULES DAILY, ORAL, AS NEEDED, ON (B)(6) 2019; PRIMPERAN (METOCLOPRAMIDE) 10 MG, 1 TO 3 TABLETS DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; LOVENOX (ENOXAPARIN NATRIUM) 4000 UI (40MG)/0.4 ML, 1 SYRINGE DAILY, S.C., FROM (B)(6) 2019; SPASFON LYOC (PHLOROGLUCINOL) 80 MG, 1-3 LYOPHYILISATES DAILY, ORAL, AS NEEDED, FROM (B)(6) 2019; GLUCIDION G5 (GLUCOSE, NACL, KCL) 1000 ML/24H, ONCE, I.V., ON (B)(6) 2019 AND POLYIONIQUE GLUCOSE 5% (GLUCOSE, NACL, KCL) 1000ML/24 H, ONCE DAILY, I.V., ON (B)(6) 2019. THE PATIENT RECOVERED AND WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2019. REPORTER'S COMMENTS: THE INVESTIGATOR ASSESSED THE EVENT AS DEFINITELY RELATED TO SIR-SPHERES MICROSPHERES (MEDIAL DEVICE). NO CAUSALITY ASSESSMENT FOR SIR-SPHERES MICROSPHERES MAPPING AND IMPLANT PROCEDURE, CISPLATIN AND GEMCITABINE WAS PROVIDED. THIS REPORT HAS ALSO BEEN SUBMITTED AS AN IDE REPORT FOR # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219390 | SIR-SPHERES® Y-90 RESIN MICROSPHERES | MICROSPHERES | NAW | SIRTEX TECHNOLOGY PTY LTD / SIRTEX MEDICAL LIMITED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization | ACTISKENAN| ACTISKENAN| ACTISKENAN| ALPRAZOLAM ARROW| ALPRAZOLAM ARROW| ALPRAZOLAM ARROW| ATARAX| ATARAX| ATARAX| CONTRAMAL| CONTRAMAL| CONTRAMAL| DOLIPRANE| DOLIPRANE| DOLIPRANE| GLUCIDION G5| GLUCIDION G5| GLUCIDION G5| LIDOCAINE/PRILOCAINE AGUETTANT 5%| LIDOCAINE/PRILOCAINE AGUETTANT 5%| LIDOCAINE/PRILOCAINE AGUETTANT 5%| LOVENOX| LOVENOX| LOVENOX| MORPHINE (CHLORHYDRATE) AGUETTANT| MORPHINE (CHLORHYDRATE) AGUETTANT| MORPHINE (CHLORHYDRATE) AGUETTANT| ONDANSETRON ACCORD| ONDANSETRON ACCORD| ONDANSETRON ACCORD| POLYIONIQUE GLUCOSE 5%| POLYIONIQUE GLUCOSE 5%| POLYIONIQUE GLUCOSE 5%| PRIMPERAN| PRIMPERAN| PRIMPERAN| PRINPERAN| PRINPERAN| PRINPERAN| SPASFON LYOC| SPASFON LYOC| SPASFON LYOC| TRANSILANE| TRANSILANE| ACTISKENAN| ALPRAZOLAM ARROW| ATARAX| CONTRAMAL| DOLIPRANE| GLUCIDION G5| LIDOCAINE/PRILOCAINE AGUETTANT 5%| LOVENOX| MORPHINE (CHLORHYDRATE) AGUETTANT| ONDANSETRON ACCORD| POLYIONIQUE GLUCOSE 5%| PRIMPERAN| PRINPERAN| SPASFON LYOC |